The Recall Desk
HighFDA (Devices)·Z-2519-2026·Announced 2026-06-24

HeartMate 3 system controllers recalled over backup battery failures

HeartMate 3 System Controllers, model 106531US, are being recalled due to 11 volt backup battery failures. 694 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 3 System Controller, model/catalog number 106531US, UDI/GTIN 05415067039446, from Thoratec LLC, is being recalled. The controller acts as the central power and communication hub for the system. The action covers 694 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 controllers 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: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the P
Manufacturer
Thoratec LLC
Category
Medical Device — Ventricular assist system
Hazard
Affected units
694

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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