The Food and Drugs Administration (FDA), United States posted a medical device safety alert concerning Companion External Battery, Part Number: 293001-001, manufactured by SynCardia Systems, Inc.
According to the FDA, 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 are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
The manufacturer 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.
For details, please visit the following FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0620-2013&w=01092013&lang=eng
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 10 January 2013