Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process. Find out more about this #MedicalDevice recall. https://go.usa.gov/xwWCk  
Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process. Find out more about this #MedicalDevice recall. https://go.usa.gov/xwWCk  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

On June 1st, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures.pic.twitter.com/mGsbP4C8be
On June 1st, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures. pic.twitter.com/mGsbP4C8be (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

We apologize for today's technical difficulties. A transcript from today's Town Hall will be available by June 9th. We have also confirmed the dial-in information for our next Town Hall call on June 10, 2020 is correct.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Emergency department data collected by CDC surveillance networks indicate some patients may be delaying emergency care during the #COVID19 pandemic. Fewer visits for critical conditions might result in complications or death. Learn more from @CDCMMWR: http://bit.ly/MMWR6320   .pic.twitter.com/Z6tUdtTVL7
Emergency department data collected by CDC surveillance networks indicate some patients may be delaying emergency care during the #COVID19 pandemic. Fewer visits for critical conditions might result in complications or death. Learn more from @CDCMMWR: http://bit.ly/MMWR6320 . pic.twitter.com/Z6tUdtTVL7 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at CDCgov) Source Type: news

REMINDER https://twitter.com/FDADeviceInfo/status/1266434402919288836   …
REMINDER https://twitter.com/FDADeviceInfo/status/1266434402919288836 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 3, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Consumer and health care personnel safety is a top priority for FDA. We ’ re working with industry to increase access to hand sanitizers and ensure that harmful levels of impurities are not present in ethanol used in these products. https://go.usa.gov/xwj9T   pic.twitter.com/KEtwKNB3Da
Consumer and health care personnel safety is a top priority for FDA. We’re working with industry to increase access to hand sanitizers and ensure that harmful levels of impurities are not present in ethanol used in these products. https://go.usa.gov/xwj9T  pic.twitter.com/KEtwKNB3Da (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 2, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Today, @US_FDA is providing an update on Allergan ’ s latest actions to inform patients who may not be aware of the July 2019 BIOCELL breast implants and tissue expanders recall. Find out more. https://go.usa.gov/xwbRP  
Today, @US_FDA is providing an update on Allergan’s latest actions to inform patients who may not be aware of the July 2019 BIOCELL breast implants and tissue expanders recall. Find out more. https://go.usa.gov/xwbRP  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 1, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

#DYK women are nearly 2x more likely to develop Alzheimer ’ s Disease compared to men? Researchers are conducting clinical trials to better understand this disease & inform future treatment. Learn more about clinical trials: http://www.clinicaltrials.gov   pic.twitter.com/6QdC0ZSy8z
#DYK women are nearly 2x more likely to develop Alzheimer’s Disease compared to men? Researchers are conducting clinical trials to better understand this disease & inform future treatment. Learn more about clinical trials: http://www.clinicaltrials.gov  pic.twitter.com/6QdC0ZSy8z (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 1, 2020 Category: Medical Devices Authors: ( at FDAWomen) Source Type: news

Today kicks off National CPR and AED Awareness Week. Please consider taking a few minutes to learn more about the life-saving capabilities of automated external defibrillators and how to use them. https://go.usa.gov/xw4XT   #CPRAEDAwarenessWeek
Today kicks off National CPR and AED Awareness Week. Please consider taking a few minutes to learn more about the life-saving capabilities of automated external defibrillators and how to use them. https://go.usa.gov/xw4XT  #CPRAEDAwarenessWeek (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 1, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

REMINDER: Flagging for developers of tests for SARS-CoV-2: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests. Wednesday June 3, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx   pic.twitter.com/WxLDFGp6uW
REMINDER: Flagging for developers of tests for SARS-CoV-2: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests. Wednesday June 3, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx  pic.twitter.com/WxLDFGp6uW (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Protect your water supply & ensure #foodsafety, by knowing what to do before, during & after a #storm https://go.usa.gov/xw4Kn   #HurricaneSeasonpic.twitter.com/lqbR93cWmn
Protect your water supply & ensure #foodsafety, by knowing what to do before, during & after a #storm https://go.usa.gov/xw4Kn  #HurricaneSeason pic.twitter.com/lqbR93cWmn (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2020 Category: Medical Devices Authors: ( at FDAfood) Source Type: news

We're kicking off our 2020 Annual Public Forum next month with a fireside chat where @pgoldberg14 sits down with @SteveFDA to discuss shared goals and how @US_FDA is helping to battle #COVID19. Register at http://bit.ly/2I4117z   .pic.twitter.com/N90ZpmrdJ5
We're kicking off our 2020 Annual Public Forum next month with a fireside chat where @pgoldberg14 sits down with @SteveFDA to discuss shared goals and how @US_FDA is helping to battle #COVID19. Register at http://bit.ly/2I4117z . pic.twitter.com/N90ZpmrdJ5 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2020 Category: Medical Devices Authors: ( at MDIConline) Source Type: news

Do you have questions about glove shortages or manufacturing, purchasing, or importing gloves? Check out the @US_FDA ’ s comprehensive resource about medical gloves during the #COVID19 public health emergency. https://go.usa.gov/xw4D9  
Do you have questions about glove shortages or manufacturing, purchasing, or importing gloves? Check out the @US_FDA’s comprehensive resource about medical gloves during the #COVID19 public health emergency. https://go.usa.gov/xw4D9  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 29, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The clamp screws are at risk of breaking when tightening the strain relief clamp and outflow graft tears have been observed before, during, or shortly after implant. Find out more about this #MedicalDevice recall. https://go.usa.gov/xwgWw  
The clamp screws are at risk of breaking when tightening the strain relief clamp and outflow graft tears have been observed before, during, or shortly after implant. Find out more about this #MedicalDevice recall. https://go.usa.gov/xwgWw  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 28, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up.pic.twitter.com/m68O7tKrDG
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up. pic.twitter.com/m68O7tKrDG (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 28, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news