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 |
|
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 |