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SynCardia Systems Inc. recalls Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers
Recalled September 23, 2015 · FDA recall Z-2731-2015 · SynCardia Systems
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. · FDA Class I
Units
56 drivers (21 currently in use on patients)
Sold at
Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France.
Description
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.
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.
Manufacturer(s)
SynCardia Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →