Heartware recalls HVAD Pump Kit REF 1104CA-CLIN due to hardened driveline cover causing delayed access to pump connections, potentially leading to patient harm during emergencies.
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 its HVAD Pump Kit (REF 1104CA-CLIN) because the driveline cover can harden over time, making it difficult to access the pump connection. This delay could cause serious harm if the patient needs urgent pump maintenance.
The driveline cover can harden over time, making it difficult to slide back to access the pump connection. If the cover becomes hardened, healthcare providers may not be able to quickly connect the pump during emergencies, which could lead to patient harm.
Patients using the Heartware HVAD Pump Kit with serial numbers HW24101 through HW24104 and HW24755, HW24763 are affected. Those with the specific pump kit model are most at risk.
Check for the Heartware HVAD Pump Kit with serial numbers HW24101, HW24102, HW24103, HW24104, HW24755, or HW24763. The product was sold with the reference number 1104CA-CLIN.
If the driveline cover appears hardened, contact your Medtronic field representative for assessment and possible servicing.
The recalled pump kit has reference number 1104CA-CLIN.
Check the serial numbers: HW24101, HW24102, HW24103, HW24104, HW24755, or HW24763.
Contact your Medtronic field representative for further 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-0747-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0747-2023 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.
