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

Class II

Recalling firm: Thoratec LLC
Reason for recall: Due to 11 volt Backup Battery failures.
Affected products (lot / model / serial): Lot Code: Model Number: 106128 UDI/GTIN 05415067039880 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
Units affected: 12
Distribution pattern: 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.
Firm location: Pleasanton, CA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2520-2026
Recall initiated: May 13, 2026
FDA classification date: June 18, 2026
FDA report date: June 24, 2026
FDA event ID: 99023
Last updated on HTM Vibe: July 23, 2026