Heartware recalls HVAD Driveline Extension Cable REF 100 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 Driveline Extension Cable (REF 100) because clinical studies show it has a higher risk of neurological issues and death compared to other ventricular assist devices. This recall is important for patients using the device as it could lead to serious health complications.
The device has been linked to a higher frequency of neurological adverse events and mortality in clinical studies. Additionally, the internal pump may delay or fail to restart, which could lead to life-threatening situations.
Patients using the Heartware HVAD system with the REF 100 driveline extension cable are most at risk. This recall applies to individuals who have received the device as part of their medical treatment.
Check for the Heartware HVAD Driveline Extension Cable with model REF 100. The product has specific serial numbers listed in the recall notice and was sold with GTINs 00888707009294, 008:88707000345, and 00763000187651.
Look for the specific serial numbers listed in the recall notice: 00888707009294, 00888707000345, or 00763000187651.
Heartware is recalling the HVAD Driveline Extension Cable (REF 100) due to clinical studies showing a higher frequency of neurological adverse events and mortality compared to other ventricular assist devices.
The recall notice does not mention a specific fix or remedy for the device.
Check the serial numbers listed: 00888707009294, 00888707000345, or 00763000187651.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2192-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2192-2021 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.
