Events

Recall of Boston Scientific

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
    33529
  • Event Risk Class
    Class 1
  • Event Number
    Z-0041-06
  • Event Initiated Date
    2005-09-23
  • Event Date Posted
    2005-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42034
  • 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
    Endoscopic Injection Needle, Gastroenterology-Urology - Product Code FBK
  • Reason
    Incorrect implantation may cause serious health complications.
  • Action
    Boston Scientific issued Recall notification by FED'X on 9/23/05 as follows Customers/ Hospital Account / Distributors: A Recall Notification Package will be sent to the risk manager of each hospital account via FedEx. This package contains a Recall Notification Letter, instructions on how to return product, a Recall Verification Form, and a Physician Letter that provides recommendations of patient follow-up. . Physicians Trained in the Enteryx Procedure: All physicians that attended the physician training program sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided to assist in their communication to the patient. Patient Letter / Patient Phone Script: A letter and phone script, from the physician to the patient, will be provided to the physician to assist in the physician's communication to patient. The letter informs the patient of the recall and asks them to contact their physician and the Patient Phone Script provides a template to initiate a discussion with the patient. Physicians Participating in Post Approval Studies: All physicians that are participating in post approval studies will be sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone script will be provided to assist in their communication to the patient. Internal Review Boards (IRBs): All IRBs that are participating in post approval studies will be sent, via FedEx, a IRB Letter and the Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided. Boston Scientific has posted the recall to their website:http://www

Device

Boston Scientific

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Boston Scientific Pl, Natick MA 01760-1536
  • Source
    USFDA