Recall Atlas

SynCardia Systems recalls

2 official recalls and safety alerts involving SynCardia Systems since 2023-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with SynCardia Systems or the relevant agency.

  1. 2023-11-01
  2. US
    Drugs & medicalClass II

    SynCardia Systems LLC recalls SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

    Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.

    FDA · DeviceSynCardia Systems LLCUS: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi…Official notice →
  3. 2023-02-08
  4. US
    Drugs & medicalClass II

    SynCardia Systems LLC recalls SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    Due to tears reported tears in the cannula due to wear and tear stress.

    FDA · DeviceSynCardia Systems LLCWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice →