Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are co

FDA device recall Z-2731-2015 · posted 2015-09-17 · Terminated

Recall details

Recalling firm

SynCardia Systems Inc.

Reason for recall

SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function.

Action taken

SynCardia sent an Urgent Medical Device Recall letter dated August 6, 2015 to affected customers. The letter identified the purpose, reason for the voluntary recall, risk to health, how to recognize that the device may fail, actioms to be taken by the customer/user, product and distribution information and type of action by the company. Customer were instructed to completed and return Recall Acknowledgement and Receipt Form to SynCardia. A SynCardia Clinical Support Specialist or other SynCardia representative will assist customers with replacement product and returning affected product. Contact Information For Questions Mary Pat Sloan Senior Vice President Global Certification and Logistics SynCardia Systems, Inc 1992 E Silverlake Rd Tucson, AZ 85713 Direct 520-547-7470 Toll-free 866-480-1122 Ext 1308 Monday-Friday 7:30 AM to 5:00 PM Pacific/Arizona time Hotline 24/7 866-771-9437 www.syncardia.com

Root cause

Component design/selection

Status

Terminated

Product code

LOZ

Quantity affected

56 drivers (21 currently in use on patients)

Distribution

Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France.

Date initiated

2015-08-06

Date posted

2015-09-17

Date terminated

2015-11-04

Location

Tucson, AZ