Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from bivent

U.S. FDA — Device Enforcement · United States · 2015-08-06 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2731-2015
Date of alert: 2015-08-06
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: SynCardia Systems Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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