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Cardiac Assist Recalls
14 recalls on record · February 19, 2020 to September 6, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 6, 2023Medical DevicesFDA
Cardiac Assist, Inc recalls LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. No
Hazard: Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
January 25, 2023Medical DevicesFDA
Cardiac Assist, Inc recalls SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Compon
Hazard: A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.
October 5, 2022Medical DevicesFDA
Cardiac Assist, Inc recalls TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-000
Hazard: Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
December 8, 2021Medical DevicesFDA
Cardiac Assist, Inc recalls SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a
Hazard: Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)
May 5, 2021Medical DevicesFDA
Cardiac Assist, Inc recalls Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Li
Hazard: On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.
May 20, 2020Medical DevicesFDA
Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extra
Hazard: Failure to prime due to an assembly error
May 20, 2020Medical DevicesFDA
Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary
Hazard: Failure to prime due to an assembly error
May 20, 2020Medical DevicesFDA
Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides tempora
Hazard: Failure to prime due to an assembly error
May 20, 2020Medical DevicesFDA
Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary
Hazard: Failure to prime due to an assembly error
May 20, 2020Medical DevicesFDA
Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary
Hazard: Failure to prime due to an assembly error
May 20, 2020Medical DevicesFDA
Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temp
Hazard: Failure to prime due to an assembly error
May 20, 2020Medical DevicesFDA
Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides tempo
Hazard: Failure to prime due to an assembly error
May 20, 2020Medical DevicesFDA
Cardiac Assist, Inc recalls TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support
Hazard: Failure to prime due to an assembly error
February 19, 2020Medical DevicesFDA
Cardiac Assist, Inc recalls TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo
Hazard: The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.