The Recall Desk
HighFDA (Devices)·Z-0505-2026·Announced 2025-11-26

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.

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 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 Syste
Manufacturer
Thoratec LLC
Category
Medical Device — Ventricular assist device
Hazard
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

Distributed nationwide across the United States.

The notice also names 42 states specifically:

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 →

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