Home / Recalls / Thoratec Corp. / Z-2658-2023

Z-2658-2023 Class II Ongoing

Recalled by Thoratec Corp. — Pleasanton, CA

Recall Details

Product Type
Devices
Report Date
October 11, 2023
Initiation Date
August 7, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,681

Product Description

Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

Reason for Recall

Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia , Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom.

Code Information

REF/UDI-DI/Serial Numbers: 106524US/00813024013297/MLP-034137 to MLP-034744, MLP-035485 to MLP-035714, MLP-036330 to MLP-037708, MLP-038104 to MLP-038999, MLP-039000 to MLP-039999, MLP-040000 to MLP-040999, MLP-041000 to MLP-041621; 106524INT/00813024011712 (OUS)/MLP-032482, MLP-035542 to MLP-035667, MLP-037218 to MLP-037527, MLP-038008 to MLP-038989, MLP-039014 to MLP-039945, MLP-040009 to MLP-040896, MLP-041013 to MLP-041589; 1050/00813024010227: 135021-135025, 134241-134246, 134248, 134250, 134251, 134240, 135060, 135061, 135062, 134247, 132849-132853, 134239; Apical Coring Knife Distributed Separately Serial Number Range: 132849 to 135062

Other recalls by Thoratec Corp.

  • 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-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)