Heart pump implant kits recalled over corrosion at the battery connector
Thoratec is recalling 248 HeartMate II LVAS Implant Kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: corrosion affecting the backup battery path on a heart pump system is a hazard, and no injuries are reported.
Plain-English summary
The HeartMate II LVAS Implant Kit with Pocket Controller, sealed, is being recalled across models 106015 (US) and 106016 (EU).
The recall follows potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
The recall covers 248 units. All units of the listed models are impacted, with model 106015 carrying UDI 00813024011224. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
The kit supports an implanted heart pump, so its backup power path matters. The enforcement record reports no injuries. Patients and clinicians should follow Thoratec's instructions.
The recalled product
- Product
- Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The Heart
- Manufacturer
- Thoratec LLC
- Hazard
- corrosion
- backup-battery
- fault-alarm
- cardiac-support
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- it can be replaced (per the IFU) and the controller will continue to be used.
Distribution
Distributed nationwide across the United States.
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