Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Recalled by SynCardia Systems LLC Due to Due to tears reported tears in the cannula...
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 SynCardia Systems LLC directly.
Affected Products
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Quantity: 1,732 systems
Why Was This Recalled?
Due to tears reported tears in the cannula due to wear and tear stress.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SynCardia Systems LLC
SynCardia Systems LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report