Thoratec Llc: Ventricular (assist) Bypass
HeartMate 3 Left Ventricular Assist System Recall Summary Thoratec LLC is recalling HeartMate 3 Left Ventricular Assist System (LVAS) kits due to failures in the 11-volt backup battery. The HeartMate 3 is an implanted heart pump device designed to help patients with advanced heart failure by supporting the heart's function. This recall affects devices distributed worldwide, including across all U.S. states and several countries including Canada, Germany, Japan, Netherlands, Poland, and Spain.
- Recalling firm
- Thoratec LLC
- Product
- Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist...
- 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/751c9e00-ba0d-4b6c-add8-51ed4aff73bf