Heartware recalls HVAD Pump Kit REF 1104JP with serial numbers HW40657-HW41848. Hardened driveline cover may delay critical connections, risking 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 specific HVAD pump kits that may develop a hardened driveline cover. This can delay critical connections during emergencies, potentially causing patient harm if the pump needs immediate repair.
Over time, the driveline cover can harden, making it difficult to slide back to access the pump's connection. If the cover becomes hardened, patients may experience delayed emergency repairs, which could cause harm during critical situations.
Patients using the recalled Heartware HVAD pump kits with specific serial numbers are most at risk. The hazard occurs when the pump requires urgent maintenance.
Check for the Heartware HVAD Pump Kit with serial numbers listed in the recall (e.g., HW40657 to HW41848). The product is identified by the REF 1104JP model.
If the driveline cover is hardened, contact your Medtronic field representative for assessment and possible servicing.
The driveline cover may harden over time, causing delays in accessing the pump's connection during emergencies, which could lead to patient harm.
If you have the recalled pump, check if the driveline cover is hardened. If so, contact your Medtronic field representative for assessment and possible servicing.
Your pump is in the recall if it has the Heartware HVAD Pump Kit with serial numbers listed in the recall (e.g., HW40657 to HW41848).
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0748-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0748-2023 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.
