BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Safety Notice and Recall of Lithium Ion Polymer Batteries used as componets of Companion Driver Systems, Syncardia Systems Inc.

Product group Active implantable medical devices - artificial hearts
Reference 07652/12

Urgent Field Safety Notice and recall of Lithium Ion Polymer Batteries used as componets of Companion Driver Systems of TAH-t heart assist devices made by Syncardia Systems Inc.,Tucson, Arizona, USA, due to possible risk of fabrication defects.

Safety Notice and Recall of Lithium Ion Polymer Batteries used as componets of Companion Driver Systems, Syncardia Systems Inc. , Download_VeroeffentlichtAm_EN PDF, 126KB, File does not meet accessibility standards