Z-2105-2008

Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific...

Name: Z-2105-2008 Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific...
Creator: Boston Scientific Corp
Published: 2008-04-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-04-02 / Terminated / root cause: packaging

FDA source

Boston Scientific Corp began a recall of Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210. System is used... on 2008-04-02. The reason FDA records is "Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2105-2008
Status: Terminated
Initiated: 2008-04-02
Posted: 2008-09-11
Terminated: 2008-09-11
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210. System is used for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: An Urgent Medical Device Recall-Immediate Action Required letter was sent to consignees on 4/2/08 directing them to immediately discontinue use of and segregate the identified products for return to the firm and complete the verification tracking form.
Quantity in commerce: 80
Distribution: Class III Recall - Worldwide Distribution --- including USA and countries of Finland, France, Germany and Great Britain.
Product codes and lots: Lot 11374425.

Product code FGE

K965147Class IIBiliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp / cleared 1997-06-30

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)