Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Dri

FDA device recall Z-0620-2013 · posted 2012-12-28 · Terminated

Recall details

Recalling firm

SynCardia Systems Inc.

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.

Action taken

Syncardia Systems sent a" Urgent Field Safety Notice" dated December 10, 2012, to all affected customers. The letter identified the product the problem and what action the customer needs to take.. The letter informed the customers that there were 3 reported thermal battery events (2 of which occurred on-site at either SynCardia or at the battery manufacturer, Dow Kokam, and one incident that occurred in the field) which caused physical damage to the batteries including burning and/or charring. The batteries were not in use with a patient at time of the reported issue, and there were no reports of any adverse impact to any patient or user. Customers are instructed to follow the directions on the attached Return page, and return their customer response form to SynCardia as soon as possible. Customers with questions are instructed to call (520) 545-1234 or (520) 440-7593.

Root cause

Process control

Status

Terminated

Product code

DSZ

Quantity affected

81 units

Distribution

Worldwide Distribution -- US (nationwide)

Date initiated

2012-12-05

Date posted

2012-12-28

Date terminated

2013-06-07

Location

Tucson, AZ