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Recall Observatory FDA recall evidence

Device product

Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210

Z-1013-2019

December 26, 2018

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 82068
Status
Terminated
Classification
Class II
Quantity
18 units
Official record key
device-enforcement:Z-1013-2019

Official wording

Reason: The sterile barrier may contain packaging seal defects.

Code information: Lot 22960201

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The sterile barrier may contain packaging seal defects.