Events

Recall of Device Recall Medtronic Slimline Catheter

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
    34246
  • Event Risk Class
    Class 3
  • Event Number
    Z-0392-06
  • Event Initiated Date
    2005-12-09
  • Event Date Posted
    2006-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43330
  • 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
    Electrode, Ph, Stomach - Product Code FFT
  • Reason
    Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the digitrapper ph recorder. medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the digitrapper ph recorder.
  • Action
    Letters will be sent to distributors, end-users and Medtronic Field Personnel. The end-user will be asked to return via fax a confirmation/customer receipt. Letters identify the affected catalog number and lot numbers. Customers are asked to return affected product and will receive replacement product.

Device

Device Recall Medtronic Slimline Catheter
  • Model / Serial
    Lot numbers 571, 606, 695, 754, 952, 945, 1024, 1066
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, CO, FL, MA, OH, PA. OUS to include Finland, Italy and Portugal
  • Product Description
    Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Distributed by / Medtronic Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA
  • Manufacturer
    Medtronic Gastroenterology / Urology

Manufacturer

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