Heartware recalls specific HVAD pump models (1104CA-CLIN) for updated instructions on controller fault alarms and component lifespans. No immediate action needed beyond reviewing new guides.
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 HVAD pump models (1104CA-CLIN) to update instructions about when controller fault alarms occur and how to handle them. This helps users understand the device's expected lifespan and troubleshooting steps without immediate safety risks.
The recall focuses on clarifying how controller fault alarms work and the expected lifespan of pump components. This update ensures users understand when alarms indicate issues and how long parts should last, reducing confusion without immediate safety hazards.
Patients using Heartware's 1104CA-CLIN HVAD pumps with serial numbers HW24101 through HW24763 are most affected. Healthcare providers managing these devices may also need updated guidance.
Check for the model number 1104CA-CLIN on the pump. Serial numbers listed include HW24101, HW24102, HW24103, HW24104, HW24763, and HW24755FSCA.
Check for new Heartware instructions on controller fault alarms and component lifespans to ensure proper use.
No, the recall only requires reviewing updated instructions. No immediate action is needed.
The updated instructions will clarify troubleshooting steps for controller fault alarms.
The recall provides updated information on the expected lifespan of pump components.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0480-2024 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0480-2024 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.
