SynCardia 50cc TAH-t recall
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Why was SynCardia 50cc TAH-t recalled?
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots/ UDI: 00858000003053
- Product
- SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
- Recalling firm
- SynCardia Systems LLC
- Quantity
- 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
- Recall date
- November 1, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)