“We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. EUS‐guided hepaticogastrostomy using plastic stent. Plastic biliary stents ranging in length from 40 mm to 120 mm (Flexima, Boston Scientific, Marlborough, MA, USA) and SEM biliary stents ranging in length from 40 mm to 60 mm (WallFlex Uncovered, Boston Scientific, Marlborough, MA, USA) were deployed in the Elastic EHBD model with standard 8–10F catheters (N 6 per stent type). Flexima Biliary Duodenal Bend Biliary Stent w-Delivery System Boston Scientific. ©2021 Boston Scientific Corporation or its affiliates. 3931 Flexima Biliary Stent | Boston Scientific. FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO, Boston Scientific, Spencer, IN. Click here to view code information Reason of Recall. All rights reserved. Full Line of All Purpose Drainage Catheters in J-tip and locking loop pigtail configurations; Biliary Drainage Catheters; Nephrostomy Drainage Catheters; Ureteral Stents; Nephrourteral Stents The same device may have different names in different countries. An office chair was in the wrong place - at ANY time! You can download a raw copy of the database here. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Recall # Z-1994-2010 CODE 1) Units: … FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. It was reported to boston scientific corporation that a flexima biliary stent was used during a stent placement procedure of the upper bile duct performed on (b)(6) 2012. Expiration dates have mostly to do with sterilization and not the integrity of the product. The patient recovered well until she became symptomatic again in September 2007, for which an endoscopic retrograde biliary drainage (ERBD) catheter (FLEXIMA™ Biliary Stent System, Boston Scientific Co., Natick, MA, USA) was placed. Central serilisation services materials: packaging. Or have experience with a medical device? • Flexima Catheter Firm Durometer is engineered to resist typical buckling forces encountered during percutaneous insertion • R/O Marker, on the Flexima Biliary Drainage Catheters with R/O, is intended to enhance visibility and accurate placement Drainage Ability Flexima Catheters are designed for excellent drainage performance Allow for the area proximal and distal to the tumor tobe covered with the stent to protect against impingement from further tumor growth. Flexima Catheters provide the time-tested difference that you can see and feel. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a … All other trademarks are the property of their respective owners. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. Recall of the products „Flexima Biliary Stent Systems“ from Boston Scientific (Ref.nos. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Internal biliary drainage (stenting) uses a metal cylinder (called a stent) to hold the blocked area open. Flexima Biliary Stent System provides external and internal percutaneous drainage of the biliary system. (VisiGlide, Olympus). M00539220: Boston Scientific Flexima Biliary Stent, Duodenal Bend 7F x 10cm Expired » Boston Scientific » Stents: Gastrointestinal Sign in to add this product to your favorites! 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