Home / Recalls / Cardiac Assist, Inc / Z-1950-2020

Z-1950-2020 Class II Terminated

Recalled by Cardiac Assist, Inc — Pittsburgh, PA

Recall Details

Product Type
Devices
Report Date
May 20, 2020
Initiation Date
March 6, 2020
Termination Date
November 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15

Product Description

TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Reason for Recall

Failure to prime due to an assembly error

Distribution Pattern

US Nationwide distributions.

Code Information

Serial Numbers: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972

Other recalls by Cardiac Assist, Inc

  • Z-2465-2023 Class II — LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Pri (June 30, 2023)
  • Z-0926-2023 Class I — SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPA (December 5, 2022)
  • Z-1763-2022 Class I — TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 59 (July 21, 2022)
  • Z-0311-2022 Class III — SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypas (October 14, 2021)
  • Z-1486-2021 Class II — Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterizatio (March 19, 2021)
  • Z-1952-2020 Class II — TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-31 (March 6, 2020)
  • Z-1954-2020 Class II — TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3 (March 6, 2020)
  • Z-1948-2020 Class II — TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary ex (March 6, 2020)
  • Z-1949-2020 Class II — TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 57 (March 6, 2020)
  • Z-1955-2020 Class II — TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - (March 6, 2020)