Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015...
FDA Recall #Z-0507-2026 — Class II — October 9, 2025
Product Description
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries. Component: No
Reason for Recall
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Recalling Firm
Thoratec LLC — Pleasanton, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
248
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Algeria, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, Uzbekistan.
Code Information
Lot Code: All units of the following models are impacted: Model 106015 UDI: 00813024011224 Model 106016 UDI: 00813024011231 Note: Product bracketing is determined based on possible use of the controller. Since the backup battery has a 3 year life cycle, it can be replaced (per the IFU) and the controller will continue to be used.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated