Heartware recalls PUMP 1103 HVAD implant kits with serial numbers starting from HW10991 to HW27250. Updates to instructions clarify when Controller Fault alarms occur and how to troubleshoot, plus information about 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 specific models of their PUMP 1103 HVAD implant kits to update instructions for patients and healthcare providers. The updates clarify when Controller Fault alarms sound and how to respond, as well as information about the useful life of the device components. This recall does not involve immediate safety risks but aims to improve understanding of the device's operation and maintenance.
The recall involves updates to the device's instructions for use and patient manual to clarify when Controller Fault alarms occur and the recommended troubleshooting steps. It also provides information about the useful life of the system components. There is no immediate safety hazard, but better understanding of the device's operation is needed.
Patients with Heartware PUMP 1103 HVAD implant kits with serial numbers from HW10991 to HW27250 are affected. Those who have this specific implant kit model should check their serial number.
Check your Heartware PUMP 1103 HVAD implant kit's serial number. The affected units have serial numbers starting from HW10991 to HW27250.
Heartware will provide updated instructions for use and patient manual to clarify when Controller Fault alarms occur and how to respond.
The updated instructions will also include information about the useful life of the HVAD system components.
The Heartware PUMP 1103 HVAD implant kit is a ventricular assist device used for heart support in patients with heart failure.
No, this recall does not require stopping use of the device. Heartware is providing updates to instructions to improve understanding of the device's operation and component lifespan.
Check your implant kit's serial number. If it starts with HW10991 and goes up to HW27250, your device is affected.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0478-2024 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0478-2024 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.
