Thoratec LLC recalls Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery

Recalling company

Thoratec LLC

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 the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System Controller

Reason

Due to 11 volt Backup Battery failures.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 13, 2026

Reported

Jun 24, 2026

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.

Status

Ongoing

Quantity

12

Lot / codes

Lot Code: Model Number: 106128 UDI/GTIN 05415067039880 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.

Company location

Pleasanton, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-2520-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2520-2026 in the FDA Enforcement Report. Also see FDA recall press releases.