FDA Updates Class I Recall Alert For SynCardia's Bridge-To-Transplant System

27 Oct 2016

• By Sue Darcey

SynCardia Systems' Freedom Driver System was subject to a class I recall last year, and now US FDA has updated its concerns about a component of the firm's Temporary Total Artificial Heart based on post-approval study data, and is asking that malfunctioning drivers be returned to the manufacturer.

Following up on a voluntary class I recall initiated by SynCardia Systems Inc. in August 2015, US FDA provided updated information about malfunctions and mortalities with the recalled Freedom Driver and the related SynCardia TAH-t Companion 2 Driver seen in post-approval studies. The on Oct. 26 update includes a request that providers return any of these devices with problems to the manufacturer.

The devices are associated with SynCardia's Temporary Total Artificial Heart (TAH-t) system. The difference between the C2 Driver system and...