Thoratec recalls HeartMate II LVAS implant kits with potential backup battery cable corrosion causing fault alarms. Affected models 106015 and 106016 may need replacement of the backup battery.
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 LVAS implant kits that may have backup battery cable corrosion causing fault alarms. This could lead to the device not functioning properly if the backup battery fails. Affected units include specific model numbers sold in the US and EU.
The backup battery cable connector may corrode, causing a fault alarm. This could prevent the device from working properly if the backup battery fails, potentially leading to complications for the patient.
Patients with HeartMate II LVAS implant kits (model 106015 or 106016) are affected. Those who have the device implanted and use the backup battery are most at risk.
Check for model numbers 106015 or 106016 on the implant kit. The product was sold in the US and EU with sealed, pocket controller versions.
If the device displays a backup battery fault alarm, stop using it immediately.
Reach out to Thoratec directly to arrange backup battery replacement as the backup battery has a 3-year life cycle.
No, but if the device displays a backup battery fault alarm, stop using it immediately.
The backup battery has a 3-year life cycle and should be replaced as per the manufacturer's instructions.
Model 106015 (UDI: 00813024011224) and model 106016 (UDI: 00813024011231) are affected.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-0507-2026 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-0507-2026 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.
