Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01086-1
Product Name/Description	ATTAIN HYBRID Guide Wires (used to aid the placement of Medtronic transvenous left ventricular leads in the coronary vasculature) Model GWR419688 Batch Numbers: 0006840866, 0006840879, 0006873688 ARTG Number: 153354
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	22/10/2013
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic has identified the potential for an issue with a specific subset of batch numbers of the Guide Wires where the PTFE (polytetrafluoroethylene) coating could delaminate and detach from the Guide Wire. This issue affects a subset of a range of Guide Wires manufactured from mid-April 2013. Delamination and detachment of the PTFE coating may lead to embolic occlusion and thrombosis in coronary, cerebral, peripheral or pulmonary vasculature. Vascular thrombosis and/or occlusion have the potential to result in irreversible damage or injury to vital organs including myocardial infarction or stroke.
Recall Action	Recall
Recall Action Instructions	Customers are asked to quarantine all unused product for return to Medtronic. For affected products that have been used, Medtronic is advising that patients should continue to be managed in accordance with hospitals standard patient management protocol.
Contact Information	1800 668 670 - Medtronic Australasia