Temporary Total Artificial Heart — Class I medical device recall Z-2731-2015
Terminated recall by SynCardia Systems Inc., reported 2015-09-23, distributed nationwide. SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fa
| Recall number | Z-2731-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SynCardia Systems Inc., Tucson, AZ, United States |
| Recall initiated | 2015-08-06 |
| Classified | 2015-09-17 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2015-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FR, TR |
| Reason classes | device malfunction |
| Serial numbers | 030944, 031041, 031057, 031074, 031140, 031255, 031333, 031405, 031406, 031452, 031479, 031487, 031541, 031623, 031823, 4506, 4507, 4514, 4517, 4521, 4542, 4546, 4559, 4573, 4592 and 141 more |
| Model numbers | 595000-001 |
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.