Recall Z-2520-2026— Thoratec LLC

Class II FDA medical device recall by Thoratec LLC, initiated 2026-05-13. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm

Thoratec LLC

Classification

Class II

Status

Ongoing

Initiated

2026-05-13

Firm location

Pleasanton, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.