Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 7, 2018
Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cook Medical Incorporated recalled Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage:… - a moderate-severity action.
Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage:… was recalled by Cook Medical Incorporated in November 7, 2018. Reason: The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the s…. Check the official notice for the remedy. Verify recall #Z-0343-2019 with the FDA Devices before acting.
The recall
Cook Medical Incorporated issued this moderate-severity FDA Devices recall-The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the s….
- Moderate
- severity level
- Class II
- classification
- November 7, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0343-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0343-2019) was formally reported on November 7, 2018, with the manufacturer initiating the action on September 25, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Cook Medical Incorporated is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 9834 total.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, V…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
9834 total
Related Recalls
6
0 from same agency
Product description
Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0343-2019 |
| Date reported | November 7, 2018 |
| Date initiated | September 25, 2018 |
| Recalling firm | Cook Medical Incorporated |
| Firm location | Bloomington, IN |
| Affected scope | 9834 total |
| Distribution | US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, a… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0343-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.. Recalled by Cook Medical Incorporated. Units affected: 9834 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2018. Severity: Moderate. Recall number: Z-0343-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0343-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 7, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.