Home / Recalls / Thoratec LLC / Z-0505-2026

Z-0505-2026 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
29059

Product Description

Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 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

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 106524US UDI: 00813024013297 Model 106524INT UDI: 0081302401171 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-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-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)