Class II — SynCardia Systems LLC
| Recalling firm | SYNCARDIA SYSTEMS, LLC |
|---|---|
| Registered facility | SYNCARDIA SYSTEMS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to tears reported tears in the cannula due to wear and tear stress. |
| Product | SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000 |
| Quantity | 1,732 systems |
| 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, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain,… |
| Initiated | 2022-11-02 |
| Classified | 2023-01-27 |
| Recall number | Z-1022-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SynCardia Systems LLC (Z-1022-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91330/
Alerts for SYNCARDIA SYSTEMS, LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.