Heartware recalls specific HVAD pump models (US) for updated instructions on controller fault alarms and component lifespans to ensure safe use.
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 ventricular assist pumps (Model 1101) to update instructions for handling controller fault alarms and component lifespans. This helps users understand when alarms occur and how long parts last, reducing confusion and potential misuse.
The recall updates instructions for when controller fault alarms sound and what to do. It also clarifies how long the pump's components last. Without these updates, users might not know when to act or how long parts are safe to use, potentially causing confusion.
Patients using the Heartware HVAD pump Model 1101 with the listed serial numbers are affected. Those with the device are most at risk if they misunderstand the instructions for handling alarms or component lifespans.
Check if your pump has the Model Number 1101 and one of the listed serial numbers (e.g., HW1005, HW1015, etc.). The device is used in the U.S. for heart support.
Read the new instructions for controller fault alarms and component lifespans to understand when to act and how long parts last.
Heartware is updating instructions for controller fault alarms and component lifespans to help users understand when alarms occur and how long parts last.
No, the recall does not require stopping use. Updated instructions help users manage alarms and component lifespans safely.
Review the updated instructions for controller fault alarms and component lifespans to ensure safe use.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0476-2024 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0476-2024 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.
