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

Recall Z-0659-2017 — 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

U.S. FDA — Device Enforcement · United States · 2016-10-21 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0659-2017
Date of alert
2016-10-21
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
SynCardia Systems Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00858000003121
Reported risk: 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.
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.

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