Cardiac Assist, Inc recalls

14 recalls on record · latest: June 30, 2023

Official U.S. recall history for Cardiac Assist, Inc, compiled from official government records.

Get recall alerts

Free email alert whenever Cardiac Assist, Inc has a new recall — straight from official government data. Unsubscribe anytime.

Cardiac Assist, Inc recalls LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note:…

June 30, 2023 · Medical device recalls Moderate risk Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. i…

SHIP KIT recalled over injury risk

December 5, 2022 · Medical device recalls High risk A software update (v1.1.5) has been developed to address the issue of Critical…

TANDEM LIFE LivaNova LIFESPARC Controller recalled over injury risk

July 21, 2022 · Medical device recalls High risk Critical Failure of the LifeSPARC controller when the software freezes or crash…

Cardiac Assist, Inc recalls SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components:…

October 14, 2021 · Medical device recalls Top label of the outer package of the collection kit Item 5820-3118 showed expi…

Cardiac Assist, Inc recalls Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Lif…

March 19, 2021 · Medical device recalls Moderate risk On 02/26/2021, it was found that there were incorrectly packaged Dilator sets i…

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary…

March 6, 2020 · Medical device recalls Moderate risk Failure to prime due to an assembly error

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides tempo…

March 6, 2020 · Medical device recalls Moderate risk Failure to prime due to an assembly error

Cardiac Assist, Inc recalls TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support…

March 6, 2020 · Medical device recalls Moderate risk Failure to prime due to an assembly error

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary e…

March 6, 2020 · Medical device recalls Moderate risk Failure to prime due to an assembly error

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary ex…

March 6, 2020 · Medical device recalls Moderate risk Failure to prime due to an assembly error

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracor…

March 6, 2020 · Medical device recalls Moderate risk Failure to prime due to an assembly error

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporar…

March 6, 2020 · Medical device recalls Moderate risk Failure to prime due to an assembly error

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides tempo…

March 6, 2020 · Medical device recalls Moderate risk Failure to prime due to an assembly error

Cardiac Assist, Inc recalls TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo…

November 19, 2019 · Medical device recalls Moderate risk The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous…