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

• Date Initiated by Firm: December 26, 2018
• Create Date: March 14, 2019
• Recall Status: Terminated on April 17, 2020
• Recall Number: Z-1013-2019
• 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) x7cm, Material Number M00539210
• Code Information: Lot 22960201
• FEI Number: 3005099803
• 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: Other
• Action: Urgent Medical Device Product Removal notification letters dated 12/26/18 were sent to customers.
• Quantity in Commerce: 18 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