RegWardenFDA facility compliance records
Company

SYNCARDIA SYSTEMS, LLC

5 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2015: 1 recalls; 2016: 1 recalls; 2022: 1 recalls; 2023: 1 recalls1’12’13’141’151’16’17’18’19’20’211’221’23’24’25’26
  • Recalls (5)

Registered facilities (1)

Recalls & enforcement

  • Class IICompleted2023-08-01
    Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
  • Class IIOngoing2022-11-02
    Due to tears reported tears in the cannula due to wear and tear stress.
  • Class ITerminated2016-10-21
    The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.
  • Class ITerminated2015-08-06
    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.
  • Class IITerminated2012-12-05
    Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SYNCARDIA SYSTEMS, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9067898-syncardia-systems-llc/

Not open yet

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.

Planned

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.