Heartware recalls HVAD Pump Kit REF 1104 with serial numbers HW25347 to HW35999 due to hardened driveline cover that may delay access to the pump connector, risking patient harm during emergencies. Contact Medtronic for assessment.
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 1104 (serial numbers HW25347 to HW35999) because the driveline cover can harden over time, making it difficult to access the pump connector. This delay could cause harm if urgent repairs are needed. Affected users should contact Medtronic for assessment.
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 connect or troubleshoot the pump during emergencies, potentially causing harm.
Patients using Heartware HVAD pumps with the recalled kit (serial numbers HW25347 to HW35999) are most at risk. The hazard is specific to this model and its serial numbers.
Check your Heartware HVAD Pump Kit serial number against the list: HW25347 to HW35999 (the full list is provided in the recall notice).
Verify your pump kit's serial number against the list of affected units (HW25347 to HW35999).
If your pump is affected, contact Medtronic for assessment and possible servicing.
The recall is for Heartware HVAD Pump Kit REF 1104 with serial numbers HW25347 to HW35999.
Check your pump kit's serial number against the list of affected units (HW25347 to HW35999).
Contact Medtronic for assessment and possible servicing.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0746-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0746-2023 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.
