Heartware recalls HVAD Outflow Graft REF MCS172: Higher neurological adverse events and mortality risk compared to other ventricular assist devices. Affected units include specific serial numbers and GTINs.
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 Outflow Graft model REF MCS1725OG due to higher rates of neurological issues and death compared to other ventricular assist devices. This recall is based on clinical data showing the device may delay or fail to restart the internal pump.
The device has been linked to higher neurological adverse events and mortality in clinical studies. Additionally, the internal pump may delay or fail to restart, which could impact patient safety.
Patients using the Heartware HVAD Outflow Graft with serial numbers listed in the recall are affected. Those with the specific GTINs or model numbers mentioned are at higher risk.
Check the serial number on your Heartware HVAD Outflow Graft. The recall includes specific serial numbers and GTINs: 00888707007627 and 00888707007634.
Look for the serial number on your Heartware HVAD Outflow Graft to confirm if it's in the recall list.
Heartware is recalling the HVAD Outflow Graft due to higher rates of neurological adverse events and mortality compared to other ventricular assist devices, as well as pump restart issues.
Check the serial number on your device. If it matches the recall list (serial numbers or GTINs provided), contact Heartware for further instructions.
The recall record does not mention a specific remedy or fix for the device.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2196-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2196-2021 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.
