Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29659 |
| Brand Name: | Zilver 635 - Biliary self expanding stent |
| Model: | Cook Medical Zilver Biliary Stents G37276 CK-ZIB6-40-10-6.0 and G37277 CK-ZIB6-40-10-8.0 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Cook Ireland Ltd |
| Issue: | The manufacturer has implemented an IFU update for the Zilver Biliary Stents. There is no change to the manufacturing process, device, or design. This change does not affect the quality, safety, or effectiveness of the device. The Warnings and Potential Adverse Events have been updated. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/7/2022 |
