Heartware recalls HVAD Pump Kit REF MCS1705PU due to hardened driveline cover causing delayed access to pump connections, potentially leading to patient harm. Affected units have specific serial numbers.
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 MCS1705PU) because the driveline cover can harden over time, making it difficult to access the pump connection. This delay in fixing urgent issues could harm patients needing immediate pump support.
The driveline cover can harden over time, preventing easy access to the pump connection. If urgent issues arise, delayed repairs could cause prolonged pump stoppage, risking patient harm.
Patients using Heartware HVAD Pump Kit with specific serial numbers are affected. Those with the recalled model who rely on timely pump access for medical emergencies are at higher risk.
Check your Heartware HVAD Pump Kit for serial numbers listed in the recall (e.g., HW41765, HW42068, etc.). The product was sold with specific model reference MCS1705PU.
If the cover is hardened, contact your Medtronic field representative for assessment and possible servicing.
The driveline cover can harden over time, making it difficult to access the pump connection. This delay in fixing urgent issues could lead to patient harm.
Check if your serial number is listed in the recall. If the cover is hardened, contact your Medtronic field representative for assessment and possible servicing.
The affected units have specific serial numbers listed in the recall (e.g., HW41765, HW42068, etc.) and use the model reference MCS1705PU.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0750-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0750-2023 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.
