Tucson, AZ, United States
SynCardia Systems LLC recalls
2 recalls recorded since 2018, most recently on 1 August 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 1 August 2023
- Reason
- Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0126-2024
- SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Ongoing Class II Medical devices
- Recall started
- 2 November 2022
- Reason
- Due to tears reported tears in the cannula due to wear and tear stress.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Le
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1022-2023
- SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.