Cook Endoscopy Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used in palliation neoplasms in the biliary tree. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used in palliation neoplasms in the biliary tree.
Brand
Cook Endoscopy
Lot Codes / Batch Numbers
Lot number W2528796
Products Sold
Lot number W2528796
Cook Endoscopy is recalling Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, I due to A section of the introduction system may detach after the stent has deployed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A section of the introduction system may detach after the stent has deployed.
Recommended Action
Per FDA guidance
The consignee was notified by letter on/about 09/11/2008. The distributor was instructed to contact their customers and coordinate the return of all affected product to Cook Endoscopy. A responds form was attached to the letter to be completed and returned to Cook Medical to confirm receipt of notification and indicate quantity to be returned. Contact Cook Endoscopy at 1-336-744-0157, ext. 6325 for assistance.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL
Page updated: Jan 10, 2026