Events

Recall of Device Recall Concerto

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

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
    32764
  • Event Risk Class
    Class 2
  • Event Number
    Z-1456-05
  • Event Initiated Date
    2005-07-15
  • Event Date Posted
    2005-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40787
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.
  • Action
    Consignees were advised by recall letter dated July 25, 2005 and requested to return all units on hand.

Device

Device Recall Concerto
  • Model / Serial
    Lots 7575613, 7583594, 7715339 and 7730068.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Germany, Italy, Netherlands, Spain and Sweden.
  • Product Description
    Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Manufacturer Address
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source
    USFDA