Thoratec recalls HeartMate 3 Controller models due to potential corrosion in backup battery cable connector causing fault alarms. Affected units may need replacement of 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 3 Controller devices because of potential corrosion in the backup battery cable connector that could trigger a fault alarm. This issue does not cause immediate harm but requires attention to prevent false alarms or system failures.
Corrosion in the backup battery cable connector can cause a fault alarm to activate. This may lead to false alarms or system malfunctions, but does not pose a direct risk of injury or death.
Patients using HeartMate 3 LVAS systems with the specified controller models are affected. Those with the backup battery nearing its 3-year life cycle may be at slightly higher risk.
Check for the HeartMate 3 Controller models: 106531US, 106531INT, or 106531LF2. The recall applies to all units with the listed model numbers and UDI codes.
Identify your HeartMate 3 Controller model number from the product label or documentation.
Reach out to Thoratec for guidance on whether your controller needs a backup battery replacement.
No, only specific controller models (106531US, 106531INT, 106531LF2) are affected.
Corrosion in the backup battery cable connector can trigger a fault alarm, potentially leading to false alarms or system malfunctions.
The recall states this issue does not cause injury or death but may lead to false alarms or system failures.
We’ve drafted a message you can send HeartMate to request your refund or repair — edit it as you like.
Subject: Recall Z-0506-2026 — HeartMate HeartMate Hello, I own a HeartMate that is covered by recall Z-0506-2026 from HeartMate. 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.
