RegWardenFDA facility compliance records
Facility

SYNCARDIA SYSTEMS, LLC

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2015: 1 recalls; 2016: 1 recalls; 2017: 1 inspections; 2018: 1 inspections, 1 warning letters; 2022: 1 recalls; 2023: 1 recalls1’12’13’141’151’161’172’18’19’20’211’221’23’24’25’26
  • Recalls (5)
  • Inspections (2)
  • Warning letters (1)

Devices registered here (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.

FDA inspections (2)

  • NAI2018-11-29
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • OAI2017-08-18
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SYNCARDIA SYSTEMS, LLC (FEI 3003761017) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003761017-syncardia-systems-llc/

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