The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2518-2026·Announced 2026-06-24

HeartMate 3 assist system kits recalled over backup battery failures

HeartMate 3 Left Ventricular Assist System kits, model 106524US, are being recalled due to 11 volt backup battery failures. Four units are affected.

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: 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

HeartMate 3 Left Ventricular Assist System (LVAS) Kits, model/catalog number 106524US, UDI/GTIN 05415067039323, from Thoratec LLC, are being recalled. The action covers four 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 kits 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 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a…
Manufacturer
Thoratec LLC
Category
Medical Device — Ventricular assist system
Hazard
Affected units
4

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 →

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