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SynCardia Systems Inc. recalls Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2
Recalled January 9, 2013 · FDA recall Z-0620-2013 · SynCardia Systems
Hazard
Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning. · FDA Class II
Units
81 units
Sold at
Worldwide Distribution -- US (nationwide)
Description
Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.
Product
Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
Manufacturer(s)
SynCardia Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →