SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Reported: February 8, 2023 Initiated: November 2, 2022 #Z-1022-2023
Product Description
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Reason for Recall
Due to tears reported tears in the cannula due to wear and tear stress.
Details
- Recalling Firm
- SynCardia Systems LLC
- Units Affected
- 1,732 systems
- Distribution
- 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.
- Location
- Tucson, AZ
Frequently Asked Questions
What product was recalled? ▼
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000. Recalled by SynCardia Systems LLC. Units affected: 1,732 systems.
Why was this product recalled? ▼
Due to tears reported tears in the cannula due to wear and tear stress.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2023. Severity: Moderate. Recall number: Z-1022-2023.
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