The Recall Desk
HighFDA (Devices)·Z-2520-2026·Announced 2026-06-24

HeartMate 11 volt lithium ion backup batteries may fail

HeartMate 11 Volt Lithium Ion Standalone Backup Batteries, model 106128, are being recalled due to 11 volt backup battery failures. Twelve units are affected.

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: FDA Class II recall where the backup power source of a circulatory support system can fail, a risk of harm with no injuries reported in the source.

Plain-English summary

The HeartMate 11 Volt Lithium Ion Standalone Backup Battery, model/catalog number 106128, UDI/GTIN 05415067039880, from Thoratec LLC, is being recalled. The battery is a component of the HeartMate system. The action covers 12 units, identified by the serial numbers in the recall notice.

The stated reason is 11 volt backup battery failures. The FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States across states including Alabama, Arkansas, Arizona and California. The batteries are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the model number, UDI/GTIN and serial numbers in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to
Manufacturer
Thoratec LLC
Category
Medical Device — Ventricular assist system
Hazard
Affected units
12

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Thoratec LLC

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Same hazard · battery failure

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