FDA-Device2023-02-08Class II
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
SynCardia Systems LLC
Hazard
Due to tears reported tears in the cannula due to wear and tear stress.
Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Affected count
1,732 systems
Manufactured in
1992 E Silverlake Rd, N/A, Tucson, AZ, United States
Products
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1022-2023Don't want to check this manually?
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