Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00088-2
Product Name/Description	ISOLINE 2CR6 and 2CT6 Implantable Defibrillation Leads Previous ARTG numbers (cancelled in Nov 2011) : 165673, 165674 Multiple serial numbers
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	31/01/2013
Responsible Entity	Sorin Group Australia
Reason/Issue	As of December 31, 2012, 30 cases of internal insulation breach under the RV or SVC defibrillation coil have been confirmed by the analysis conducted on returned products. In each of the 30 identified cases, the internal insulation breach of the silicone lumen was observed under the RV and/or SVC defibrillation coil, i.e. where the microcables are not coated with ETFE, resulting in a contact between the conductors, thus leading to low pacing impedance and/or ventricular oversensing, and/or inappropriate therapy. It should be noted that in case of ventricular oversensing, pacing is inhibited.
Recall Action	Hazard Alert
Recall Action Instructions	Sorin Group Australia is issuing a 'Hazard Alert' letter to implanting/ treating clinicians and hospitals detailing the issues and how to manage the affected patients. The TGA has published a web statement regarding the issues. For more information, please see http://www.tga.gov.au/safety/alerts-device-isoline-leads-130306.htm .
Contact Information	1800 452 650 - Sorin Group