Heart pump kits recalled over corrosion at the backup battery connector
Thoratec is recalling 29,059 HeartMate 3 Left Ventricular System kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 3 Left Ventricular Assist System (LVAS) Kits are being recalled across models 106524US, 106524INT and 106524.
The recall follows potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
The recall covers 29,059 units. All units of the listed models are impacted, with model 106524US carrying UDI 00813024013297. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
The system 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 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist…
- Manufacturer
- Thoratec LLC
- Affected units
- 29,059
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
Part of a larger recall action
This product is one of 4 recalled by Thoratec LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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