SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Reported: November 1, 2023 Initiated: August 1, 2023 #Z-0126-2024
Product Description
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Reason for Recall
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Details
- Recalling Firm
- SynCardia Systems LLC
- Units Affected
- 114 units
- 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
- Location
- Tucson, AZ
Frequently Asked Questions
What product was recalled? ▼
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO. Recalled by SynCardia Systems LLC. Units affected: 114 units.
Why was this product recalled? ▼
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2023. Severity: Moderate. Recall number: Z-0126-2024.
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