Thoratec Llc: Ventricular (assist) Bypass
HeartMate Backup Battery Recall Summary Thoratec LLC is recalling the 11-volt lithium-ion backup battery component in HeartMate 3 System Controllers due to battery failures. The backup battery is designed to provide emergency power to the controller for at least 15 minutes if the main power source fails. This recall affects devices distributed nationwide in the US and in Canada, Germany, Japan, Netherlands, Poland, and Spain.
- Recalling firm
- 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...
- Reason
- Due to 11 volt Backup Battery failures.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-13
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0311a7cd-ea30-4957-a886-b5a8837ae1ca