Heartware recalls Model 1101 pacemakers with hardened driveline covers that could delay critical connections, risking patient harm during emergencies. 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 Model 1101 pacemakers because the driveline cover can harden over time, making it difficult to access the connector. This delay could cause serious harm if urgent repairs are needed. Owners should contact their Medtronic representative for assessment.
Over time, the driveline cover may harden, making it difficult or impossible to slide back to access the connector. If the cover cannot be accessed quickly during an urgent issue, the pump may stop, potentially causing serious harm to the patient.
Owners of Heartware Model 1101 pacemakers with specific serial numbers listed in the recall are affected. Patients with these devices are at risk if the driveline cover hardens and prevents timely access to the connector during emergencies.
Check if your Heartware Model 1101 pacemaker has a serial number from the list provided in the recall. The list includes specific serial numbers like HW1146, HW1205, and others.
If you have a hardened driveline cover, reach out to your Medtronic field representative for assessment and possible servicing.
The driveline cover may harden over time, making it difficult to access the connector. This delay could cause serious harm if urgent repairs are needed.
Contact your Medtronic field representative for assessment and possible servicing if you observe a hardened driveline cover.
Yes. The recall includes specific serial numbers listed in the record, such as HW1146, HW1205, and others.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0743-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0743-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
