Heartware recalls PUMP 1104 HVAD implant kits with serial numbers HW10001-HW23653. Updates to instructions clarify controller fault alarms and component lifespan. No immediate action needed but users should review updated manuals.
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 specific PUMP 1104 HVAD implant kits (serial numbers HW10001 to HW23653) to update instructions for handling controller fault alarms and component lifespans. This recall does not require immediate action but ensures users have the latest guidance for safe use.
The recall updates instructions for handling controller fault alarms and component lifespans. The hazard is informational—users need clearer guidance to avoid confusion, but there is no immediate risk of injury or malfunction.
Patients with Heartware PUMP 1104 HVAD implant kits (serial numbers HW10001 to HW23653) are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check if your Heartware PUMP 1104 HVAD implant kit has a serial number starting with HW10001 and ending with HW23653. The full list of affected serial numbers is provided in the recall notice.
Heartware will provide updated instructions for use and patient manuals to clarify controller fault alarms and component lifespans.
No, this recall does not require stopping use. Heartware is providing updated instructions for safer use.
Review the updated instructions and patient manuals provided by Heartware to ensure proper use and understanding of component lifespans.
Check if your Heartware PUMP 1104 HVAD implant kit has a serial number in the range HW10001 to HW23653 as listed in the recall notice.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0479-2024 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0479-2024 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.
