Events

Recall of Device Recall Flexima Biliary Catheter System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52717
  • Event Risk Class
    Class 2
  • Event Number
    Z-1901-2009
  • Event Initiated Date
    2009-07-01
  • Event Date Posted
    2009-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83808
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, biliary, diagnostic - Product Code FGE
  • Reason
    Boston scientific is initiating a recall of a single batch/lot of this product. we received a report that the labeling on the device does not match the labeling on the product packaging. specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a flexima biliary catheter, which is correct, but the heat shrink inscription directly below the hub on the.
  • Action
    Boston Scientific issued an "Urgent Medical Device Recall -Immediate Action Required" letter dated July 1, 2009. The letter was addressed to Risk Manger / Field Action Contact describing the problem and units affected and that further distribution or use of affected product should cease immediately. The Reply Verification Tracking Form enclosed with the letter was requested to be completed and returned. For further information, contact Boston Scientific at 1-508-683-6036.

Device

Device Recall Flexima Biliary Catheter System
  • Model / Serial
    Lot Number: 12203269.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (AZ, AR, CO, DE, FL, GA, MI, MT, NE, NC, OH and WI), Spain, Finland and Netherlands.
  • Product Description
    Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only, Made in USA 780 Brookside Drive, Spencer, IN 47460-1080. || The catheter is designed for external and internal percutaneous drainage of the biliary system.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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. “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. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA