Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Companion External Battery Recalled by SynCardia Systems Inc. Due to Syncardia Systems is recalling the Companion External Batteries...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SynCardia Systems Inc. directly.
Affected 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.
Quantity: 81 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SynCardia Systems Inc.
SynCardia Systems Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report