Heartware recalls specific models of ventricular assist device implant kits for updated safety instructions on controller faults and component lifespans. No immediate action needed but updates clarify risks.
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Heartware is recalling certain models of ventricular assist device implant kits (MCS1705PU) to update safety instructions. This helps users understand when controller fault alarms occur and how long components last, reducing confusion about device safety.
The recall updates instructions for when controller fault alarms might sound and what to do. It also clarifies how long the device components are expected to last. These updates help prevent misunderstandings that could lead to improper use.
Patients with implanted Heartware ventricular assist devices (HVAD) using the recalled model numbers are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check your device's model number (MCS1705PU) and serial numbers listed in the recall notice. The recall includes specific serial numbers and GTINs provided in the official notice.
Heartware will provide updated instructions for use and patient manuals to clarify when controller fault alarms occur and how to handle them.
No, the recall does not require stopping use. Heartware is providing updated instructions to clarify safety concerns.
Check your device's model number (MCS1705PU) and serial numbers listed in the official recall notice.
Heartware will send updated instructions and patient manuals to help you understand when controller fault alarms occur and how long components last.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0483-2024 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0483-2024 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.
