Heartware recalls specific HVAD Sterile Implant Kit Model 1100 units with serial numbers 001-181. Updates clarify when Controller Fault alarms occur and component lifespans 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 Sterile Implant Kit Model 1100 units. The recall provides updated instructions to help users understand when Controller Fault alarms occur and how long components last, ensuring safe device use.
The recall addresses updates to instructions for use and patient manuals. These updates clarify when Controller Fault alarms sound and what to do, as well as the useful life of device components. This helps prevent confusion that could lead to improper use.
Patients with Heartware HVAD Sterile Implant Kit Model 1100 (serial numbers 001-181) are affected. Those with the device are most at risk if they don't follow the updated instructions.
Check for serial numbers starting with HW001 through HW181 on the HVAD Sterile Implant Kit Model 1100. The product is a heart assist device implanted in patients.
Read the new instructions for use and patient manual to understand when Controller Fault alarms occur and how to respond.
Heartware is updating instructions for use and patient manuals to clarify when Controller Fault alarms occur and the useful life of device components.
No, the recall does not require stopping use. Updated instructions help ensure safe operation.
Review the updated instructions for use and patient manual to understand when Controller Fault alarms occur and how to respond.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0475-2024 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0475-2024 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.
