CLASS II Device recall · Reported 7 Nov 2018 · FDA Enforcement Report

Zilver 635 Biliary Stent recalled by Cook Medical Incorporated

Cook Medical is recalling Zilver 635 Biliary Stent, distributed nationwide in the US. The recall was initiated on 25 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGPN: G36240

Quantity recalled9834 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0326-2019
FDA event ID: 81238
Recalling firm: Cook Medical, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 25 Sep 2018
FDA classified: 31 Oct 2018
Reported: 7 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

25 Sep 2018	Recall initiated by company
31 Oct 2018	Classified by FDA	+36 days
7 Nov 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it 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 lots are affected?

GPN: G36240

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

38 other products · FDA event 81238

This product is part of a recall event; the main page for the event is Zilver 635 Biliary Stent recalled by Cook Medical Incorporated.

Reported	Class	Recall	Company	Reason	Where
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver Biliary 518 Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 518 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide
7 Nov 2018	CLASS II	Zilver 635 Biliary Stent recalled by Cook Medical Incorporated	Cook Medical	Other	Nationwide

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