Heartware recalls HVAD Implant Kit REF 110: higher neurological adverse events and mortality risks compared to other LVADs. Stop using if you have this device.
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 Implant Kit (REF 1104JP) because clinical studies show it has higher rates of neurological issues and deaths compared to other ventricular assist devices. This could mean serious health risks for patients using the device.
The Heartware HVAD system has been linked to more neurological problems and higher mortality rates than other ventricular assist devices in clinical studies. Additionally, the internal pump may sometimes delay or fail to restart, which could lead to life-threatening complications.
Patients with the Heartware HVAD Implant Kit (REF 1104JP) who have received the device are most at risk. The recall affects individuals who have this specific implant kit installed.
Check for the product code REF 1104JP on the implant kit. The kit includes all serial numbers listed in the recall notice.
Immediately stop using the Heartware HVAD Implant Kit (REF 1104JP) if you have it.
Heartware is recalling the HVAD Implant Kit (REF 1104JP) because clinical studies show it has higher rates of neurological adverse events and mortality compared to other ventricular assist devices.
Stop using it now and contact Heartware for further instructions.
The recall record does not mention any fix or remedy for this product.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2194-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2194-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
