Events

Recall of Device Recall Medtronic UClip

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Cardiac Surgery Technologies.

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
    37300
  • Event Risk Class
    Class 2
  • Event Number
    Z-0968-2007
  • Event Initiated Date
    2007-02-08
  • Event Date Posted
    2007-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50304
  • 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
    Anastomotic Device Removal Tool - Product Code FZP
  • Reason
    Six lots of u-clip removal tools, catalog rem1860fw were incorrectly assembled. the nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.
  • Action
    Customers to be notified via a letter on 2/8/07. The letter will explain the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a "Recall Certificate" acknowledging the receipt of this information.

Device

Device Recall Medtronic UClip
  • Model / Serial
    lot numbers: 0610707, 0614409, 0614410, 0614411, 0614412, 0622204
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Canada.
  • Product Description
    Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
  • Manufacturer
    Medtronic Cardiac Surgery Technologies

Manufacturer

Medtronic Cardiac Surgery Technologies
  • Manufacturer Address
    Medtronic Cardiac Surgery Technologies, 7601 Northland Dr N, Minneapolis MN 55428-1088
  • Source
    USFDA