Heartware recalls HVAD Driveline Extension Cable REF 100US due to higher neurological adverse events and mortality risks compared to other LVADs. All units 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 Driv: 100US extension cable 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 reference number.
The HVAD system has been linked to higher rates of neurological problems and death in clinical studies compared to other left ventricular assist devices. Additionally, the internal pump may delay or fail to restart, which can be life-threatening.
Heartware HVAD system users with the REF 100US extension cable are affected. Patients with heart failure requiring a ventricular assist device are most at risk.
Check for the REF 100US extension cable with GTIN 00888707000024. All units are affected, so any Heartware HVAD system with this specific cable is included.
Identify if your Heartware HVAD system uses the REF 100US extension cable with GTIN 00888707000024.
Heartware recalls the REF 100US extension cable due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, as well as pump restart issues.
The recall record does not mention a remedy or fix; Heartware is stopping distribution and sale of the HVAD system.
Look for the REF 100US extension cable with GTIN 00888707000024. All units 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-2193-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2193-2021 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.
