FDA-Device2026-06-24Class IIPROCESSING DEFECT
Thoratec HeartMate 11V Li-ion Backup Battery recalled for battery failures
BATTERYNationwide distribution
Thoratec HeartMate backup battery recalled for failure risk
The HeartMate 11 Volt Lithium Ion Backup Battery, a critical component of the HeartMate 3 System Controller, can fail to provide emergency power when needed. The backup battery is designed to supply at least 15 minutes of emergency power if the main power source fails. Battery failures could prevent the system controller from operating during power loss.
- Contact Thoratec LLC immediately if you have a HeartMate 3 System Controller with model 106128 backup battery
- Do not rely solely on the backup battery for emergency power until you have contacted the manufacturer
- Check the serial number on your device against the FDA attachment to confirm if your unit is affected
Hazard
Due to 11 volt Backup Battery failures.
Sold states
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.
Affected count
12
Manufactured in
6035 Stoneridge Dr, Pleasanton, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2520-2026More Thoratec LLC recalls
- FDA-Device2026-06-24Thoratec HeartMate 3 System Controller recalled for backup battery failure risk
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