PMA · Approved
Recalled · Class I · 2023Syncardia Temporary Cardio West Total Artificial Heart (Tah-T)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syncardia Systems, LLC · LOZ Artificial Heart
Approved on Oct 15, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 553-day review. It has a Class I recall. It has been recalled 5 times, including 2 Class I recalls.
- Decided
- Oct 15, 2004
- Review
- 553 days
- Class
- Class III
- Product code
- LOZ
- Recalls
- 5 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P030011 has 84 supplements since 2005: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 3 |
| 2014 | 7 |
| 2015 | 7 |
| 2016 | 10 |
| 2017 | 11 |
| 2018 | 5 |
| 2019 | 8 |
| 2020 | 5 |
| 2022 | 2 |
| 2023 | 6 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2023 | Class II | Z-0126-2024 | Other | Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. |
| Nov 2, 2022 | Class II | Z-1022-2023 | Device Design | Due to tears reported tears in the cannula due to wear and tear stress. |
| Oct 21, 2016 | Class I | Z-0659-2017 | Process control | 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 | Class I | Z-2731-2015 | Component design/selection | 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 | Class II | Z-0620-2013 | Process control | 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. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LOZ devicesLOZ Artificial Heart: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOZ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOZ
Too few LOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LOZ
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LOZ
47in 2025
MAUDE reports naming product code LOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 32 |
| 2012 | 5 | — | 0 | 92 |
| 2013 | 3 | — | 0 | 156 |
| 2014 | 7 | — | 0 | 325 |
| 2015 | 7 | — | 0 | 421 |
| 2016 | 10 | — | 1 (1) | 422 |
| 2017 | 11 | — | 0 | 291 |
| 2018 | 5 | — | 0 | 569 |
| 2019 | 8 | — | 0 | 379 |
| 2020 | 5 | — | 0 | 264 |
| 2021 | 0 | — | 0 | 241 |
| 2022 | 2 | — | 1 | 152 |
| 2023 | 6 | — | 1 | 167 |
| 2024 | 2 | — | 0 | 80 |
| 2025 | 3 | — | 0 | 47 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P030011 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030011: Syncardia Temporary Cardio West Total Artificial Heart (Tah-T).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030011
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026