Thoratec recalls HeartMate II controllers with potential backup battery corrosion causing fault alarms. Affected models include 106017, 106762, and 107801. No immediate action needed but monitor for alarms.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Thoratec is recalling HeartMate II controllers that may have backup battery corrosion causing fault alarms. This could lead to improper device operation if the alarm isn't addressed.
Corrosion in the backup battery cable connector might trigger a fault alarm, potentially causing the device to stop working properly. This could affect the heart support system if not resolved.
HeartMate II system users with the specific controller models listed. Patients with implanted ventricular assist devices are most at risk.
Check for controller model numbers 106017, 106762, or 107801. The product includes a unique device identifier (UDI) listed for each model.
Watch for backup battery fault alarms as the controller may stop functioning properly.
The recall note states the backup battery has a 3-year life cycle and can be replaced per the manufacturer's instructions.
Models 106017, 106762, and 107801 with specific UDI numbers listed in the recall.
The recall indicates the backup battery can be replaced per the manufacturer's instructions, but no specific fix is provided in the recall notice.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-0508-2026 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-0508-2026 from Thoratec. 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.
