Heartware recalls HVAD Pump Implant Kit REF 1125 due to higher neurological adverse events and mortality risks compared to other LVADs, with internal pump failure concerns.
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 1125) because clinical studies show it has a higher rate of neurological issues and deaths compared to other ventricular assist devices. The internal pump may also fail to restart properly, posing a risk to users.
The HVAD system has been linked to more neurological adverse events and deaths than other ventricular assist devices in clinical studies. Additionally, the internal pump may delay or fail to restart, which could lead to complications for patients.
Patients who have received the Heartware HVAD Pump Implant Kit (REF 1125) are most at risk. This recall applies to individuals with a heart failure condition requiring a ventricular assist device.
Check for the Heartware HVAD Pump Implant Kit with serial numbers listed: 00888707000222, 00888707007641, or 00888707005685. This kit was sold under the REF 1125 designation.
Reach out to Heartware directly to confirm if your specific kit is affected and get guidance on next steps.
Yes, the recall applies to patients who have received the Heartware HVAD Pump Implant Kit (REF 1125).
Contact Heartware directly to confirm if your specific kit is affected and get guidance on next steps.
The internal pump may delay or fail to restart, which could lead to complications for patients.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2190-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2190-2021 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.
