Z-0349-2019Class II

Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60

Name: Z-0349-2019 Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60
Creator: Cook Medical Incorporated
Published: 2018-09-25
License: https://open.fda.gov/license/

Cook Medical LLC / initiated 2018-09-25 / Terminated / root cause: labeling and UDI

FDA source

Cook Medical Incorporated began a recall of Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of... on 2018-09-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0349-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-25
Posted: 2018-10-31
Terminated: 2020-06-04
Recalling firm: Cook Medical LLC
Product: Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction notification letters dated 9/25/18 were distributed to customers. The letter identified affected product, problem and actions to be taken. Urgent Medical Device Correction notification letters dated 9/25/18 were distributed to customers. Customers were instructed to: 1. Examine your inventory immediately to determine if you have affected product(s). 2. Read the notice carefully and communicate the correction to users. 3. Maintain a copy of this notice for your own records. 4. Ensure users are aware of the IFU modifications. 5. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter and return it via fax (812.339.7316) or email ([email protected]). Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it. 6. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to [email protected]. For questions contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.
Quantity in commerce: 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, and Puerto Rico.
Product codes and lots: GPN: G32009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0349-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0314-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0315-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0316-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0317-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0318-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0319-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0320-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0321-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0322-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0323-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0324-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0325-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0326-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0327-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0328-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0329-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0330-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0331-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0332-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0333-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0334-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0335-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0336-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0337-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0338-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0339-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0340-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0341-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0342-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0343-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0344-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0345-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0346-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0347-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0348-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0349-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0350-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0351-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0352-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31

Product code FGE

K043481Class IIModification to: Zilver 635 Biliary StentCook, Inc. / cleared 2004-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)