Heartware recalls HVAD Pump Implant Kit REF 1153 due to higher neurological adverse events and mortality compared to other LVADs. Affected units include all serial numbers sold with GTIN 0088870:000147.
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 1153) because clinical data shows it has a higher risk of neurological issues and death compared to other ventricular assist devices. This recall affects all units sold with the specific serial numbers listed.
The Heartware HVAD system has been linked to a higher frequency of neurological adverse events and mortality in clinical studies compared to other left ventricular assist devices. Additionally, the internal pump may delay or fail to restart, potentially causing complications.
Patients who have received the Heartware HVAD Pump Implant Kit (REF 1153) are most at risk. The recall applies to all units sold with the specified serial numbers.
Check the product for the model reference 'REF 1153' and the GTIN number 00888707000147. All units with these identifiers are affected.
Identify the model reference and GTIN number on the device to confirm if it matches the recalled units.
Heartware is recalling the HVAD Pump Implant Kit (REF 1153) because clinical studies show it has a higher frequency of neurological adverse events and mortality compared to other left ventricular assist devices.
The recall record does not specify a remedy, so you should check the product details to confirm if it is affected and contact Heartware directly for further guidance.
Look for the model reference 'REF 1153' and the GTIN number 00888707000147 on the device. All units with these identifiers are affected.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2191-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2191-2021 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.
