Events

Recall of Device Recall 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
    28253
  • Event Risk Class
    Class 3
  • Event Number
    Z-0633-04
  • Event Initiated Date
    2004-02-06
  • 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=31446
  • 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
    Probe And Director, Gastro-Urology - Product Code FGM
  • Reason
    The product's rear panel label could smear during use causing the serial number to be unreadible. this has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.
  • Action
    Letters dated February 6, 2004 were sent to the consignees. Enclosed with the letter to each consignee were label sticker(s) having the serial numbers of the device(s) purchased by the consignee. The letters instruct consignees to place the enclosed stickers on the devices over the previous back panel labels if the serial number of the label matches the serial number on the device. Special instructions for devices with smeared labels include the return of devices with unreadable serial numbers.

Device

Device Recall Medtronic Bravo
  • Model / Serial
    All serial numbers less than 400,000 are involved.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The devices were distributed nationwide in the United States and worldwide.
  • Product Description
    Bravo pH Monitoring System Receiver
  • Manufacturer
    Medtronic Gastroenterology / Urology

Manufacturer

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