Thoratec Llc: Ventricular (assist) Bypass
HeartMate 3 System Controller Recall Summary Thoratec LLC is recalling the HeartMate 3 System Controller, which is the power and communication hub for HeartMate 3 heart pump systems, due to failures in the 11-volt backup battery. The affected devices were distributed worldwide, including across the United States and in Canada, Germany, Japan, Netherlands, Poland, and Spain. This is a Class III recall affecting patients who use the HeartMate 3 Left Ventricular Assist System (LVAS).
- Recalling firm
- Thoratec LLC
- Product
- Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to...
- 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/529d8b3d-6881-4ede-a00d-d3a1fc45ca89