| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01282-1 |
| Product Name/Description |
Cook Medical Zilver PTX Drug-Eluting Peripheral Stent (peripheral artery stent)
ARTG: 193333 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Cook Medical has received reports of delivery system catheter fractures resulting in tip separation after deployment.
This action was undertaken prior to seeking agreement with the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Cook Medical is updating the Instructions for Use (IFU) to mitigate the risk of the delivery system catheter fracturing |
| Contact Information |
1800 777 222 - Cook Medical |