Reported Feb 8, 2023 · Ongoing
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
SynCardia Systems LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SynCardia Systems LLC · 1992 E Silverlake Rd · Tucson, AZ · 85713-3865
Is this the product you have?
- SynCardia
- Total Artificial Heart System (70CC)500101-001 SynCardia
- Total Artificial Heart System (50CC)570500-000
- Lot codes and dates
- SynCardia
- Total Artificial Heart System (70CC)500101-001 SynCardia
- Total Artificial Heart System (50CC)570500-000
- Amount recalled
- 1,732 systems
Where it was sold
Why it was recalled
Due to tears reported tears in the cannula due to wear and tear stress.
This product could cause temporary or reversible health problems — stop using it.
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