Home / Recalls / Thoratec LLC / Z-0508-2026

Z-0508-2026 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
2424

Product Description

Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The HeartMate II System Controller is a small computer that controls and monitors system operation. It sends power and operating signals to the Left Ventricular Assist Device and adjusts device operation to maintain programmed levels of cardiac support. The System Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records device performance and alarm data, and transfers the information to the HeartMate Touch Communication System. Component: Yes, HeartMate II¿ LVAS Implant Kit

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 106017 UDI: 00813024011248 Model 106762 UDI: 00813024011286 Model 107801 UDI: 00813024011996 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-0507-2026 Class II — Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catal (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)