Heartware recalls HVAD Pump Implant Kit REF 1104 due to higher neurological adverse events and mortality risks compared to other ventricular assist devices. All units with specific serial numbers are affected.
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
Heartware is recalling its HVAD Pump Implant Kit (REF 1104) because clinical studies show it has a higher risk of neurological issues and death compared to other left ventricular assist devices. This recall affects patients who have received this implant kit and may require medical evaluation.
The Heartware HVAD Pump Implant Kit has been linked to a higher frequency of neurological adverse events and mortality in clinical studies. Additionally, the internal pump may delay or fail to restart, which could lead to complications for patients relying on this device.
Patients who have received the Heartware HVAD Pump Implant Kit (REF 1104) are most at risk. The recall applies to all units with specific serial numbers listed in the official notice.
Check the serial number on the implant kit packaging or device. The recall includes specific serial numbers listed in the official notice, such as 00888707003063, 00888707003070, and others.
Verify if your implant kit has one of the specific serial numbers listed in the official recall notice.
Heartware is recalling the HVAD Pump Implant Kit (REF 1104) due to clinical studies showing a higher frequency of neurological adverse events and mortality compared to other left ventricular assist devices.
Check the serial number on your implant kit packaging or device to see if it matches the list of affected serial numbers provided in the recall notice.
The recall notice does not specify a remedy or fix; Heartware has stopped distribution and sale of the HVAD System.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2189-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2189-2021 from Heartware. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
