Home / Recalls / Cardiac Assist, Inc / Z-1955-2020

Z-1955-2020 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
13

Product Description

TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - 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: 00142463 00142464 00142465 00142469 00142470 00142471 00142472 00142478 00142479 00142480 00142481 00142482 00142483

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-1950-2020 Class II — TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5 (March 6, 2020)
  • Z-1949-2020 Class II — TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 57 (March 6, 2020)