Recall Z-0620-2013— SynCardia Systems Inc.
Class II · Terminated
Class II FDA medical device recall by SynCardia Systems Inc., initiated 2012-12-05, terminated 2013-06-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- SynCardia Systems Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-05
- Terminated
- 2013-06-07
- Firm location
- Tucson, AZ, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.