FDA Device recall Z-0322-2019
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
- FDA Device
- Class II
- terminated
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class II recall of Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for… by Cook Medical, citing the instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruct….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0322-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-25 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook Medical |
| Distribution | US |
Product
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Reason
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
Identifiers
| code_info | GPN: G36048 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0322-2019%22
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