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SynCardia Systems, LLC

Last updated September 17, 2026

About

Georgina Smith was appointed as our Chief Accounting Officer, effective June 1, 2026. Prior to her appointment, she served as Controller for SynCardia from January 2026 to May 2026. Georgina has more than 25 years of experience in accounting and finance across diverse industries, including regulated utilities, advanced battery technology, aerospace & defense manufacturing, and mining. Before joining SynCardia, she served as Assistant Corporate Controller of Rain Bird Corporation from January 2024 to October 2025, where she was responsible for enterprise accounting governance, internal controls, financial reporting, regulatory compliance, and audit readiness. From May 2014 to December 2023, she held positions of increasing responsibility at Tucson Electric Power, including Manager of External Reporting from January 2018 to December 2023. Ms. Smith holds a Master of Business Administration and a Bachelor of Science in Accounting from the University of Arizona and is a Certified Public Accountant in the State of Arizona.

From the manufacturer's own website. Source

Information

Country: US
Address: 1992 E Silverlake Rd, TUCSON, AZ, 85713
Website: www.syncardia.com/
LinkedIn: linkedin.com/company/syncardia-systems-inc./posts
Facebook: facebook.com/SynCardia
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3003761017
DUNS Number: —

Catalogue (27)

Device	Model / Reference	Registries	Class	Status
SynCardia Freedom® Battery Charger Set Shipping Container	395103-001	FDA UDI	Class III	Active
SynCardia Companion Rechargeable LI-ION Battery	293001-001	FDA UDI	Class III	Active
SynCardia Companion Battery Shipping Container	197603-001	FDA UDI	Class III	Active
SynCardia 50cc TAH-t Surgical Spares Kit	550177-001	FDA UDI	Class III	Active
SynCardia Hand Pump	397004-001	FDA UDI	Class III	Active
SynCardia Companion Driver Caddy	397001-001	FDA UDI	Class III	Active
SynCardia Companion Hospital Cart	397003-001	FDA UDI	Class III	Active
SynCardia Freedom® Power Adaptor	295070-001	FDA UDI	Class III	Active
SynCardia Hand Pump Shipping Container	297052-001	FDA UDI	Class III	Active
SynCardia Companion 2 Driver	397002-001	FDA UDI	Class III	Active
SynCardia Freedom® Home AC Power Supply	295600-001	FDA UDI	Class III	Active
SynCardia 50cc TAH-t, Clinical	570500-001	FDA UDI	Class III	Active
SynCardia temporary Total Artificial Heart System	500101-001	FDA UDI	Class III	Active
SynCardia Companion AC Input Power Cord	197053-001	FDA UDI	Class III	Active
SynCardia Freedom® Hospital AC Power Supply	295400-001	FDA UDI	Class III	Active
SynCardia Freedom® Standby Kit Shipping Container	295104-100	FDA UDI	Class III	Active
SynCardia Freedom® Driver	595000-001	FDA UDI	Class III	Active
SynCardia Freedom® Car Charger	295053-001	FDA UDI	Class III	Active
SynCardia Freedom® Battery Charger	295054-001	FDA UDI	Class III	Active
SynCardia Companion Driver Caddy Shipping Container	297043-001	FDA UDI	Class III	Active
SynCardia 70cc TAH-t Surgical Spares Kit	500177-001	FDA UDI	Class III	Active
SynCardia Freedom® Discharge Kit Shipping Container	295101-100	FDA UDI	Class III	Active
SynCardia Companion Hospital Cart Shipping Container	197069-001	FDA UDI	Class III	Active
SynCardia Companion Driver Shipping Container	297032-100	FDA UDI	Class III	Active
SynCardia Companion Drivelines	193002-001	FDA UDI	Class III	Active
SynCardia Freedom® Onboard Battery	295025-001	FDA UDI	Class III	Active
Syncardia Temporary Total Artificial Heart (tah-T) System	P030011	FDA PMA	Class III	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 1, 2023	Z-0126-2024	—	completed	Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Nov 2, 2022	Z-1022-2023	—	open, classified	Due to tears reported tears in the cannula due to wear and tear stress.
Oct 21, 2016	Z-0659-2017	—	terminated	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.
Aug 6, 2015	Z-2731-2015	—	terminated	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.
Dec 5, 2012	Z-0620-2013	—	terminated	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.