FDA Enforcement
Class II
Completed
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Recall: Z-0126-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0126-2024
- Event ID
- 92930
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- SynCardia Systems LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 1, 2023
- Initiation Date
- August 1, 2023
- Classification Date
- October 20, 2023
- Address
- 1992 E Silverlake Rd, N/A, Tucson, AZ, 85713-3865, United States
Description
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Reason
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Code Info
All Lots/ UDI: 00858000003053
Distribution
US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia
Quantity
114 units