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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.

Jason reedMedtronic incDrug administrationMedtronic mechanical circulatory support customer serviceJason reed theImplant kitsHeartware ventricular assist devicePump implant kitImplant kitUrgent medical device communication letterHigh priorityMedium priorityController displayVentricular assist devicePhysician confirmation formஜேசன் நாணல்

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.

Heartware ventricular assist devicePump implant kitImplant kitsUrgent medical device communication letterImplant kitHigh priorityMedium priorityController displayVentricular assist devicePhysician confirmation formபம்ப் உள்வைப்பு கிட்உள்வைப்பு கருவிகள்அவசரம் மருத்துவ சாதனம் தொடர்பு கடிதம்உள்வைப்பு கிட்உயர் ப்ரையாரிடீநடுத்தர ப்ரையாரிடீ

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