Events

Recall of Medtronic Bravo

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Gastroenterology / Urology.

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
    28951
  • Event Risk Class
    Class 2
  • Event Number
    Z-0924-04
  • Event Initiated Date
    2004-04-28
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32859
  • 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
    System, Gastrointestinal Motility (Electrical) - Product Code FFX
  • Reason
    Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.
  • Action
    Letters dated April 28, 2004 were sent to the consignees. Enclosed with the letter to each consignee were replacement power cord(s). The letters instruct consignees to replace the current power cord by following instructions enclosed with the letter.

Device

Medtronic Bravo

Manufacturer

Medtronic Gastroenterology / Urology
  • Manufacturer Address
    Medtronic Gastroenterology / Urology, 4000 Lexington Ave N, Shoreview MN 55126-2917
  • Source
    USFDA