Heartware recalls specific HVAD implant kits (model 1205) for updated instructions on controller fault alarms and component lifespans. Affected units require revised manuals to ensure safe device operation.
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 HVAD implant kits (model 1205) to provide clearer instructions about when controller fault alarms occur and how to troubleshoot them. This update helps ensure patients understand the device's lifespan and safety protocols.
The recall addresses potential confusion about when the device's controller fault alarms sound and how to respond. Without updated instructions, users might misinterpret alarms or mishandle device components, affecting long-term safety.
Patients with Heartware HVAD implant kits (model 1205) and their healthcare providers. Those most at risk are individuals using the recalled units who may not have updated instructions for handling device alarms.
Check for the model number 1205 on the implant kit. Affected units have specific serial numbers listed in the recall notice, including many starting with 'HW' followed by numbers.
Heartware will provide revised instructions for use and patient manuals to clarify controller fault alarms and component lifespans.
Heartware is updating instructions for the HVAD implant kit to better explain when controller fault alarms occur and how to troubleshoot them, as well as the useful life of device components.
No. The recall does not require stopping use; it provides updated instructions to help users understand alarms and device lifespan.
Check the model number on your implant kit. Affected units are model 1205 with specific serial numbers 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-0482-2024 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0482-2024 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.
