Home / Recalls / Cardiac Assist, Inc / Z-2465-2023

Z-2465-2023 Class II Ongoing

Recalled by Cardiac Assist, Inc — Pittsburgh, PA

Recall Details

Product Type
Devices
Report Date
September 6, 2023
Initiation Date
June 30, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17

Reason for Recall

Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

Distribution Pattern

US Nationwide distribution in the states of IL, FL.

Code Information

S/N and UDI: (1)Kit 5830-2916 Pump SN 00876971 UDI: ( 01)00814112020609(11)230411(17)250219(21)00876971 (2)Kit 5840-2417 Pump SN 00876972 UDI: (01)00814112020609(11)230411(17)250219(21)00876972

Other recalls by Cardiac Assist, Inc

  • 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-1951-2020 Class II — TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-29 (March 6, 2020)
  • Z-1948-2020 Class II — TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary ex (March 6, 2020)
  • 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-1953-2020 Class II — TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720 (March 6, 2020)
  • Z-1950-2020 Class II — TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5 (March 6, 2020)