Heartware Model 1102 devices with specific serial numbers may have hardened driveline covers that 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 Model 1102 devices with certain serial numbers may have a driveline cover that hardens over time, making it difficult to access the pump connector. This could delay critical repairs during emergencies, potentially causing patient harm.
Over time, the driveline cover may harden, making it difficult to slide back to access the pump connector. If access is delayed during an urgent issue, it could cause patient harm by preventing timely repairs.
Patients using Heartware Model 1102 devices with the listed serial numbers are most at risk. The hazard affects the device's ability to be accessed during emergencies.
Check if your Heartware Model 1102 device has a serial number listed in the provided range (e.g., HW951, HW1000, etc.).
Identify your Heartware Model 1102 device's serial number to see if it matches the list of affected numbers provided in the recall.
If your serial number is on the list, contact your Medtronic field representative for assessment and possible servicing.
Heartware Model 1102 devices with specific serial numbers listed in the recall (e.g., HW951, HW1000, etc.) are affected.
The driveline cover may harden over time, making it difficult to access the pump connector during emergencies, which could delay critical repairs and cause patient harm.
No, but if the cover is hardened, contact Medtronic for assessment. The recall does not require immediate discontinuation.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0744-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0744-2023 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.
