FDA Device recall Z-2731-2015
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the Syn…
- FDA Device
- Class I
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class I recall of Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the Syn… by Syncardia Systems, citing 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 lo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2731-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-08-06 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Syncardia Systems |
| Distribution | US |
Product
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 use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
Reason
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.
Identifiers
| code_info | Part Number: 595000-001 Motor Gearbox Serial # CGI Lot # SynCardia Lot # Freedom Driver Serial # 859…Part Number: 595000-001 Motor Gearbox Serial # CGI Lot # SynCardia Lot # Freedom Driver Serial # 85979-013 85979 031479 4506 85979-022 85979 031479 4506 85977-033 85977 031333 4507 85976-020 85976 031041 4514 85976-010 85976 030944 4517 85976-014 85976 030944 4517 85979-014 85979 031479 4517 85979-021 85979 031479 4517 85976-039 85976 031074 4521 85977-001 85977 031074 4521 85978-034 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2731-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.