Boston Scientific Corporation: Stents, Drains And Dilators For The Biliary Ducts
Recall Summary Boston Scientific Corporation is recalling CRE Pro Wireguided biliary stents (12-15mm, 240cm) distributed worldwide because the sterile packaging pouches may have been compromised. This is a Class II recall affecting devices distributed across the United States, Canada, Australia, and numerous other countries. The affected devices are used to treat blockages in the bile ducts.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE Pro Wireguided 12-15mm 240cm
- Reason
- Potential sterile breach of the pouches in which devices are packaged.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c9304c61-b9a5-44bc-b5f4-59b05454d25b