Heartware recalls HVAD Pump Kit REF 1103 due to hardened driveline cover that may delay access to the pump connector, risking patient harm during emergencies. Affected units have specific serial numbers listed in the recall.
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
Heartware is recalling HVAD Pump Kit REF 1103 because the driveline cover can harden over time, making it difficult to slide back to access the pump connector. If the cover becomes hardened, users may not be able to quickly address emergencies that require connecting the pump, potentially causing harm to the patient.
The driveline cover can harden over time, creating difficulty or inability to slide it back to access the pump connector. This delay in accessing the connector during emergencies could result in patient harm if urgent pump connections or controller issues need immediate attention.
Patients using Heartware HVAD Pump Kit REF 1103 are most at risk. The recall affects specific units with serial numbers listed in the recall notice.
Check if your Heartware HVAD Pump Kit has the REF 1103 model and the specific serial numbers listed in the recall notice. The serial numbers are provided in the recall record.
Inspect the driveline cover for signs of hardening. If it's hardened, contact your Medtronic field representative for assessment and servicing.
Heartware recalls HVAD Pump Kit REF 1103 because the driveline cover can harden over time, making it difficult to access the pump connector during emergencies.
If you observe a hardened driveline cover, contact your Medtronic field representative for further assessment and servicing.
Check if your Heartware HVAD Pump Kit has the REF 1103 model and the 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-0745-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0745-2023 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.
