Heartware recalls HVAD Sterile Implant Kit Model 1102 (serial numbers HW1000-HW999) for updated instructions clarifying controller fault alarms and component lifespan.
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 its HVAD Sterile Implant Kit Model 1102 to update instructions for patients and healthcare providers. This helps clarify when controller fault alarms occur and how to address them, as well as the expected lifespan of device components.
The recall updates instructions for use (IFU) and patient manuals to clarify when controller fault alarms sound and the recommended troubleshooting steps. It also addresses the useful life of device components. These updates are for clarity and safety, but do not indicate an immediate hazard.
Patients with Heartware HVAD Sterile Implant Kit Model 1102 (serial numbers HW1000-HW999) and their healthcare providers. Those most at risk are patients who have the device implanted and are using the kit.
The Heartware HVAD Sterile Implant Kit Model 1102 with serial numbers from HW1000 to HW999. This kit is used for heart assist devices in patients who have undergone implantation.
Heartware will provide updated instructions for use and patient manuals to clarify controller fault alarms and component lifespan.
No, this recall is for updated instructions to clarify when controller fault alarms occur and how to address them, as well as the useful life of device components. It does not indicate an immediate hazard.
Review the updated instructions for use and patient manuals provided by Heartware to clarify controller fault alarms and component lifespan.
Check if your Heartware HVAD Sterile Implant Kit Model 1102 has a serial number from HW1000 to HW999.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0477-2024 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0477-2024 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.
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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.
