Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
TANDEM LIFE LivaNova LIFESPARC Controller Recalled by Cardiac Assist, Inc Due to Critical Failure of the LifeSPARC controller when the...
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
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Quantity: 723 units (484 currently in field)
Why Was This Recalled?
Critical Failure of the LifeSPARC controller when 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