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Terminated

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

FDA Recall Z-1012-2019 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2018-12-26
Date Terminated2020-04-17
Product Quantity75 units

Reason for Recall

The sterile barrier may contain packaging seal defects.

Firm Action

Urgent Medical Device Product Removal notification letters dated 12/26/18 were sent to customers.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K965147BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESISBoston Scientific Corp · 1997-06-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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