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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00359-1
Product Name/Description	Zilver PTX Drug-Eluting Peripheral Stent Catalogue numbers: ZIV6*****PTX All lot numbers affected ARTG Number: 193333
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	26/04/2013
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical has received a number of complaint reports relating to the delivery system for the Zilver PTX Drug Eluting Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section. This recall follows from a previous recall for product correction RC-2012-RN-01282-1.
Recall Action	Recall
Recall Action Instructions	Cook Medical is initiating the recall of Zilver PTX devices since there is a higher than expected potential of inner delivery catheter breakage due to inconsistencies in the catheter manufacturing process. The recall is intended to address the patient risks that may be associated with the potential failure mode.
Contact Information	07 3841 1188 - Cook Medical Recall Officer