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U.S. Department of Health and Human Services

Class 2 Device Recall Flexima Duodenal Bend Biliary Stent with Delivery System

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  Class 2 Device Recall Flexima Duodenal Bend Biliary Stent with Delivery System see related information
Date Initiated by Firm December 26, 2018
Create Date March 14, 2019
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-1012-2019
Recall Event ID 82068
510(K)Number K965147  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
Product Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Code Information Lot 22960202
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 The sterile barrier may contain packaging seal defects.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP.
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