Data / Medical devices / United States / Syncardia Systems, LLC
Syncardia Systems, LLC: FDA-registered device maker in Tucson, AZ, United States, 1 PMA approval
Syncardia Systems, LLC is registered with the FDA (registration 3003761017) in Tucson, AZ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated October 15, 2004. 5 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003761017
- Address
- 1992 E Silverlake Rd, Tucson, AZ, United States, 85713
- Owner or operator
- SYNCARDIA SYSTEMS, LLC (9067898)
- Roles
- Manufacturer
- First device listed
- November 26, 2007
- Registered through
- 2026
- Brand names listed
- SynCardia Systems, LLC Total Artificial Heart
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Artificial Heart | LOZ | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 15, 2004 | P030011 | SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) | LOZ | 84 | July 9, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 1, 2023 | 92930 | Class II | Completed | SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO | Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. | accessdata.fda.gov |
| November 2, 2022 | 91330 | Class II | Ongoing | SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000 | Due to tears reported tears in the cannula due to wear and tear stress. | accessdata.fda.gov |
| October 21, 2016 | 75600 | Class I | Terminated | 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 | 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. | accessdata.fda.gov |
| August 6, 2015 | 71905 | Class I | Terminated | 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 us | 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. | accessdata.fda.gov |
| December 5, 2012 | 63915 | Class II | Terminated | Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial | 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. | accessdata.fda.gov |
Updated July 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.