Class I — SynCardia Systems Inc.
| Recalling firm | SYNCARDIA SYSTEMS, LLC |
|---|---|
| Registered facility | SYNCARDIA SYSTEMS, LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function. |
| Product | Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital. |
| Quantity | 56 drivers (21 currently in use on patients) |
| Distribution | Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France. |
| Initiated | 2015-08-06 |
| Classified | 2015-09-17 |
| Terminated | 2015-11-04 |
| Recall number | Z-2731-2015 |
| 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 I recall — SynCardia Systems Inc. (Z-2731-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71905/
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.