| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00625-1 |
| Product Name/Description |
Cordis PRECISE PRO RX Nitinol Stent System (Carotid)
Multiple Catalogue Numbers affected
Multiple Lot Numbers affected
ARTG Number: 149399 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Based on complaints and a subsequent investigation, the manufacturer has detected an increased frequency of users reporting difficulty with stent deployment and/or separation of the bond between sections of the device outer member.
The reported issues may result in an intra-procedural delay for the patient while a replacement device is prepped. Partial stent deployment may result in vessel damage (carotid dissection or perforation, vessel spasm) requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment. In most severe cases, partial stent deployment may potentially result in Transient Ischaemic Attack or stroke.
Cordis have isolated the issue to product manufactured between 27 April 2015 and 22 November 2015.
Product that has been manufactured after 22 November 2015 is not affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are asked to immediately identify and quarantine all products listed in the customer letter in a manner that ensures the affected products will not be used and to complete the attached acknowledgement form, follow the instructions given and to forward this notice to anyone in your facility that needs to be informed. This action has been closed-out on 04/05/2017. |
| Contact Information |
1800 252 194 - JJM Customer Service |