Cook, Inc. Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-8.0-40. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-8.0-40.
Brand
Cook, Inc.
Lot Codes / Batch Numbers
Lot 1557057.
Products Sold
Lot 1557057.
Cook, Inc. is recalling Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm due to The side of the boxes give incorrect sizes for these stents. The label front is correct.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The side of the boxes give incorrect sizes for these stents. The label front is correct.
Recommended Action
Per FDA guidance
Consignees were notified via telephone on 1/26/06 and a follow-up fax was sent.
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
CA, PA, UT
Page updated: Jan 10, 2026