FDAFDA · Food and drugs·Recall number Z-0126-2024
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Published November 1, 2023 · Recall initiated: August 1, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SynCardia Systems LLC
- Distributor
- 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
- Lot
- All Lots/ UDI: 00858000003053
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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