Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
SHIP KIT Recalled by Cardiac Assist, Inc Due to A software update (v1.1.5) has been developed to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cardiac Assist, Inc directly.
Affected Products
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
Quantity: 763 (US only)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cardiac Assist, Inc
Cardiac Assist, Inc has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report