Heartware recalls HVAD Pump Implant Kit REF 1103 due to higher neurological adverse events and mortality risks compared to other ventricular assist devices.
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 110:3) because clinical studies show it has a higher rate of neurological issues and deaths compared to other left ventricular assist devices. This could be dangerous for patients with heart failure who need this implantable device.
The Heartware HVAD system has been linked to more neurological problems and deaths in clinical studies compared to other ventricular assist devices. Additionally, the internal pump may sometimes delay or fail to restart, which could be life-threatening for patients.
Patients who have been implanted with the Heartware HVAD Pump Implant Kit (REF 1103) are most at risk. The recall affects individuals with heart failure who require a ventricular assist device.
This recall applies to the Heartware HVAD Pump Implant Kit with reference number 1103. All units have a serial number that can be checked against the provided GTIN: 00888707003261.
Look for the serial number on the implant kit to confirm if it matches the recalled model (REF 1103).
Yes, if you have a Heartware HVAD Pump Implant Kit (REF 1103) implanted, this recall applies to your treatment.
The official recall does not specify a remedy, so contact Heartware directly for guidance on next steps.
The recall notes higher rates of neurological adverse events and mortality compared to other devices, but does not specify immediate injury risks.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2188-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2188-2021 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.
