Zilver 635 Biliary Stent 4mm x 80mm — Class II medical device recall Z-0331-2019
Terminated recall by Cook Medical Incorporated, reported 2018-11-07, distributed nationwide. The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the st
| Recall number | Z-0331-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Medical Incorporated, Bloomington, IN, United States |
| Recall initiated | 2018-09-25 |
| Classified | 2018-10-31 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 9,834 total |
| Model numbers | ZIB6-125-4.0-80 |
Product
Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0331-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.