This is part of a larger recall. The most authoritative record is FDA-Device / Z-2519-2026.
FDA-Device2026-06-24Class IIPROCESSING DEFECT
Thoratec HeartMate 3 Left Ventricular Assist System recalled for backup battery failure risk
BATTERYNationwide distribution
Thoratec HeartMate 3 heart pump recalled for battery failures
Thoratec has recalled certain HeartMate 3 Left Ventricular Assist System (LVAS) kits 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, the Netherlands, Poland, and Spain. Four units are known to be affected.
- Contact your cardiologist or the hospital managing your device immediately if you have a HeartMate 3 LVAS.
- Do not rely solely on the backup battery without confirming its status with your care team.
- Thoratec and your healthcare provider will provide specific instructions for your device.
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
4
Manufactured in
6035 Stoneridge Dr, Pleasanton, CA, United States
Products
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 Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2518-2026More Thoratec LLC recalls
- FDA-Device2026-06-24Thoratec HeartMate 11V Li-ion Backup Battery recalled for battery failures
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