Z-1022-2023 Class II Ongoing
FDA device recall Z-1022-2023 was initiated by SynCardia Systems LLC on November 2, 2022 and is designated Class II. Reason for recall: Due to tears reported tears in the cannula due to wear and tear stress. The recall status is ongoing. Affected quantity: 1,732 systems.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2023
- Initiation Date
- November 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,732 systems
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.
Distribution Pattern
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.
Code Information
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000