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Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. ....

Medtronic Patient Services , Drug Administration , Implant Kit , Heartware Ventricular Assist Device , Urgent Medical Device Correction , Implant Kits , Customer Confirmation Form ,

Medtronic Heart Valve Recall 2021 Update | Console and Associates, P.C.

Medtronic Heart Valve Recall 2021 Update | Console and Associates, P.C.
jdsupra.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from jdsupra.com Daily Mail and Mail on Sunday newspapers.

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Medtronic Stops Selling Heart Pump Device Tied to 13 Deaths, FDA Issues Warning

For patients that still have the pump, the FDA said U.S. doctors should contact the company for the latest guidance on managing the device, which includes managing blood pressure. ....

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Class I Recall: Medtronic HVAD Pump Implants

Class I Recall: Medtronic HVAD Pump Implants
Sean Marsala
© REUTERS/Jason Reed
The corporate logo of the U.S. Food and Drug Administration (FDA), which handles recalls and safety standards for a variety of products including food, medicine, and medical devices.
A high-priority new recall has been issued for Medtronic HVAD Pump Implant Kits. These kits are used in patients suffering from severe heart disease, especially those in need of a transplant but who have not yet found a donor. When this issue occurs, the pumps will not react as intended to restart the heart. Delays and failed reactivations can result in further heart damage or even death. So far, there have been 19 serious incidents and 2 deaths attributed to the equipment. ....

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Medtronic Recalls HVAD Pump Implant Kits After 2 Deaths and 19 Serious Injuries

Medtronic Recalls HVAD Pump Implant Kits After 2 Deaths and 19 Serious Injuries
LVAD may have delayed or failed restart after pump is stopped
March 1, 2021 Medtronic is recalling the HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit because the left ventricular assist device (LVAD) device may fail to initially start, restart, or have a delay in restarting after the pump was stopped. These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations.
If the device has delays or fails to start or restart, this could cause serious patient harm including a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death. ....

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