Z-1012-2019Class II

Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220

Name: Z-1012-2019 Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Creator: Boston Scientific Corporation
Published: 2018-12-26
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-12-26 / Terminated / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220 on 2018-12-26. FDA classified it as Class II and gives the reason as "The sterile barrier may contain packaging seal defects". 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-1012-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-26
Posted: 2019-03-14
Terminated: 2020-04-17
Recalling firm: Boston Scientific Corporation
Product: Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The sterile barrier may contain packaging seal defects.
Root cause tag: packaging
FDA root cause: Other
Action: Urgent Medical Device Product Removal notification letters dated 12/26/18 were sent to customers.
Quantity in commerce: 75 units
Distribution: The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
Product codes and lots: Lot 22960202

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1012-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1012-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-14
Z-1013-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)