FDAAugust 6, 2015device
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 biventricu...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
syncardia systemssyncardia
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDANicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.2026-05-14
- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
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- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDABrand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membra...2026-05-11
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