Heartware recalls HVAD Pump Kit REF 1205 with serial numbers listed. Hardened driveline cover may cause delays in accessing the pump connector, 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 its HVAD Pump Kit model REF 1205 because the driveline cover can harden over time, making it difficult to access the pump connector. This delay could cause serious harm if urgent repairs are needed. Affected patients should check their serial numbers against the list provided.
The driveline cover may harden over time, making it difficult to slide back to access the pump connector. If the cover becomes hardened, delays in connecting the pump could cause serious harm during emergencies like sudden equipment failure.
Patients using Heartware HVAD Pump Kit REF 1205 with the listed serial numbers are most at risk. This device is used for heart failure treatment and requires regular maintenance.
Check if your Heartware HVAD Pump Kit has a serial number from the list provided in the recall notice. The product is identified by the REF 1205 model and specific serial numbers.
Inspect the driveline cover for hardening; if it's difficult to slide back to access the connector, contact your Medtronic field representative.
The recalled model is Heartware HVAD Pump Kit REF 1205.
Check your serial number against the list of 197+ serial numbers provided in the recall notice.
Contact your Medtronic field representative for further assessment and/or servicing.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0749-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0749-2023 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.
