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Cardiac Assist, Inc FDA Recalls

5 recalls on file across devices, 2 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. NoClass IIJun 30, 2023Epoxy used during manufacturing of the LifeSPARC Pump may h	Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may resu	Class IIDevices	Jun 30, 2023
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. ComponClass IDec 5, 2022A software update (v1.1.5) has been developed to address the	A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the	Class IDevices	Dec 5, 2022
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-000Class IJul 21, 2022Critical Failure of the LifeSPARC controller when the softwa	Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not disp	Class IDevices	Jul 21, 2022
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: aClass IIIOct 14, 2021Top label of the outer package of the collection kit Item 58	Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (corr	Class IIIDevices	Oct 14, 2021
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem LiClass IIMar 19, 2021On 02/26/2021, it was found that there were incorrectly pack	On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021,	Class IIDevices	Mar 19, 2021

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