Heartware recalls Model 1100 pacemakers with serial numbers HW001 to HW181 due to hardened driveline covers that may delay critical access, 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 Model 1100 pacemakers with specific serial numbers because the driveline cover can harden over time, making it difficult to access the connector. This delay in critical repairs could cause serious harm to patients during emergencies.
Over time, the driveline cover may harden, preventing easy access to the connector. This delay could cause serious harm if urgent repairs or controller issues arise and immediate access is needed.
Patients using Heartware Model 1100 pacemakers with the listed serial numbers are most at risk. The hazard primarily affects individuals who require urgent medical interventions involving the pacemaker.
Check your Heartware Model 1100 pacemaker for the specific serial numbers listed in the recall notice. The serial numbers range from HW001 to HW181.
Identify your pacemaker's serial number to confirm if it is in the recall list (HW001 to HW181).
If you have a hardened driveline cover, contact your Medtronic field representative for assessment and possible servicing.
The driveline cover may harden over time, causing delays in accessing the connector during emergencies, which could lead to patient harm.
Check your serial number against the list provided. If it's recalled, contact Medtronic for assessment and possible servicing.
Yes, if the hardened cover delays critical access during an urgent issue, it could cause patient harm.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0742-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0742-2023 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.
