FDA-Device2013-01-09Class II
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.
SynCardia Systems Inc.
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.
Sold states
Worldwide Distribution -- US (nationwide)
Affected count
81 units
Manufactured in
1992 E Silverlake Rd, N/A, Tucson, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0620-2013Don't want to check this manually?
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