Home / Recalls / Thoratec LLC / Z-0507-2026

Z-0507-2026 Class II Ongoing

Recalled by Thoratec LLC — Pleasanton, CA

Recall Details

Product Type
Devices
Report Date
November 26, 2025
Initiation Date
October 9, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
248

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.

Distribution Pattern

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.

Other recalls by Thoratec LLC

  • Z-1099-2026 Class II — CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag R (October 10, 2025)
  • Z-0505-2026 Class II — Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) (October 9, 2025)
  • Z-0506-2026 Class II — Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/ (October 9, 2025)
  • Z-0508-2026 Class II — Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Mode (October 9, 2025)
  • Z-2290-2025 Class I — Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Cat (June 23, 2025)
  • Z-2291-2025 Class I — Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 10 (June 23, 2025)
  • Z-1570-2025 Class I — HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK (March 13, 2025)
  • Z-2583-2024 Class II — HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ve (June 25, 2024)
  • Z-1921-2024 Class I — Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1 (May 8, 2024)
  • Z-1692-2024 Class I — Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly (March 1, 2024)