Cardiology Alerts This is an OPML file. It can be used to export all the MedWorm RSS feeds on this topic into your personal RSS reader (usually you have to save this file to your own computer before clicking on an Import OPML command in your own feed reader to upload the file which will then import all the feeds) or it can be used by webmasters to integrate MedWorm feeds with their own website. This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

This page shows you the most recent publications within this specialty of the MedWorm directory.

Heartware Inc - HVAD Pump Implant Kit - Class 2 Recall
REF 1103***HVAD Pump Implant Kit. Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2013 Category: Medical Equipment Source Type: alerts

Edwards Lifesciences, LLC - Proplege Coronary Sinus Catheter - Class 2 Recall
Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2013 Category: Medical Equipment Source Type: alerts

Covidien LLC - Covidien MediTrace Cadence Adult Radiotransparent Defibrillation Electrode - Class 2 Recall
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2013 Category: Medical Equipment Source Type: alerts

Covidien LLC - Covidien MediTrace Cadence Pediatric Radiotransparent Defibrillation Electrode - Class 2 Recall
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2013 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - SERVOi ventilator system - Class 1 Recall
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-...
Source: Medical Device Recalls - April 26, 2013 Category: Medical Equipment Source Type: alerts

Stellate Systems - Harmonie software versions 5.1 uo to 6.2e : - Class 2 Recall
Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{...
Source: Medical Device Recalls - April 22, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ - Class 2 Recall
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2013 Category: Medical Equipment Source Type: alerts

Transonic Systems Inc - AV Loop Kit - Class 2 Recall
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2013 Category: Medical Equipment Source Type: alerts

Vital Images, Inc. - Vitrea CT MultiChamber Cardiac Functional Analysis application on Vitrea version 5.2 - Class 2 Recall
Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea¿ CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2013 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular, LLC - CARDIOHELPi - Class 2 Recall
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Muse v7 - Class 2 Recall
GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage cardiovascular information on adult and pediatrics patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2013 Category: Medical Equipment Source Type: alerts

Edwards Lifesciences, LLC - Edwards Lifesciences Crimpers - Class 2 Recall
Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2013 Category: Medical Equipment Source Type: alerts

Edwards Lifesciences, LLC - Edwards Lifesciences Crimpers - Class 2 Recall
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2013 Category: Medical Equipment Source Type: alerts

Edwards Lifesciences, LLC - Edwards Lifesciences Duraflo coated FemFlex II Femoral Arterial Cannula - Class 2 Recall
Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Discovery MR750w 3.0T System - Class 2 Recall
GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,blood vessels, and musculoskeletal regions of the body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 11, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Class 2 Recall
GE Healthcare Infinia / Infinia vc Hawkey 4 and Infinia / Infinia vc . Recall includes all Infinia systems, all configurations. Product Usage: K022960 The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tom...
Source: Medical Device Recalls - April 10, 2013 Category: Medical Equipment Source Type: alerts

AGFA Corp. - IMPAX CV 7.8 SU3 OCR Service - Class 2 Recall
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 8, 2013 Category: Medical Equipment Source Type: alerts

AGFA Corp. - IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting - Class 2 Recall
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 8, 2013 Category: Medical Equipment Source Type: alerts

Arrow International Inc - Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Cathet - Class 2 Recall
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic...
Source: Medical Device Recalls - April 4, 2013 Category: Medical Equipment Source Type: alerts

Vascular Solutions, Inc. - Guardian II and Guardian II NC Hemostasis Valve - Class 1 Recall
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, - Class 2 Recall
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 13, 2013 Category: Medical Equipment Source Type: alerts

Salyer Prn Biomedical - Century Console Base - Class 2 Recall
Century Console Base, Model #043625051b Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 1, 2013 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - ELS Cannula 15 FR - Class 2 Recall
ELS Cannula 15 FR. Used for the treatment of respiratory insufficiency in infants. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2013 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - CDI 101 Hematocrit/Oxygen Saturation Monitoring System - Class 2 Recall
CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors the blood/oxygen saturation, hematocrit and hemoglobin levels. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2013 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - Mindray DS USA Inc. - Class 2 Recall
DPM5 Monitor Product Usage: A vital signs monitor used on human patients. The target populations are adult, pediatric, and neonatal patients. The DPM5 Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and intuitive menu system. The patient parameters that can be monitored by DPM5 monitors are ECG (3- lead or 5-lead selectable), Heart Rate (HR), Pulse Rate(PR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP) , Saturation of Pulse Oxygen (SpO2), Temperature (TEMP), Invasive Blood Pressure (IBP), Carbon Dioxide (CO), Anesthetic Gases (AG) . Its design allows the oper...
Source: Medical Device Recalls - January 27, 2013 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns highflow aortic arch cannula - Class 2 Recall
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns flexible arterial cannula - Class 2 Recall
Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns highflow aortic arch cannula - Class 2 Recall
Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns flexible arterial cannula - Class 2 Recall
Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns highflow aortic arch cannula - Class 2 Recall
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns flexible arterial cannula - Class 2 Recall
Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular, LLC - CARDIOSAVE IntraAortic Balloon Pump - Class 2 Recall
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 9, 2013 Category: Medical Equipment Source Type: alerts

St Jude Medical Inc - FastCath Transseptal Guiding Introducer - Class 3 Recall
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 28, 2012 Category: Medical Equipment Source Type: alerts

SynCardia Systems Inc. - Class 2 Recall
Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 28, 2012 Category: Medical Equipment Source Type: alerts

Medtronic Inc. Cardiac Rhythm Disease Management - Medtronic Intersept Tubing Packs - Class 2 Recall
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1. Ster...
Source: Medical Device Recalls - December 28, 2012 Category: Medical Equipment Source Type: alerts

Greatbatch Medical - MobiCath BiDirectional Guiding Sheath - Class 2 Recall
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the he...
Source: Medical Device Recalls - December 22, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Advantage Workstation - Class 2 Recall
Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(version6.0 to version6.11) and only when one or both of these applications is installed: " CardIQ Xpress Pro or Plus " CardEP Advantage Workstations AW Volume Share 2 (AW version 4.4). ONLY IF ONE OF FOLL...
Source: Medical Device Recalls - December 19, 2012 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - Class 2 Recall
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements...
Source: Medical Device Recalls - December 17, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare, Dash 3000/4000/5000. - Class 2 Recall
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medi...
Source: Medical Device Recalls - December 16, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare BNP (8type Natriuretic Peptide) - Class 2 Recall
Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart f...
Source: Medical Device Recalls - December 11, 2012 Category: Medical Equipment Source Type: alerts

Mindray DS USA, Inc. d.b.a. Mindray North America - Mindray DS USA Inc. - Class 2 Recall
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) a...
Source: Medical Device Recalls - December 11, 2012 Category: Medical Equipment Source Type: alerts

Parks Medical Electronics, Inc - Cardiovascular blood flowmeter - Class 2 Recall
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Soft Flow Aortic Cannulae - Class 2 Recall
24 Fr 8mm Sft Flow Straight The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Soft Flow Aortic Cannulae - Class 2 Recall
24 Fr 8mm Sft Flow Str Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Soft Flow Aortic Cannulae - Class 2 Recall
24 Fr 8mm Sft Flow Straight Wir The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Soft Flow Aortic Cannulae - Class 2 Recall
24 Fr 8mm Soft Flow Ang W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Soft Flow Aortic Cannulae - Class 2 Recall
18 Fr 6mm Sft Flow Ang Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Soft Flow Aortic Cannulae - Class 2 Recall
24 Fr 8mm Soft Flow Ang Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Soft Flow Aortic Cannulae - Class 2 Recall
18 Fr 6mm Sft Flow Angled Wire The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - 100/120V AC, Advanced Perfusion System Platform (APS) - Class 2 Recall
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 27, 2012 Category: Medical Equipment Source Type: alerts