Events

Recall of Zinetics Manometric 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
    35094
  • Event Risk Class
    Class 3
  • Event Number
    Z-1159-06
  • Event Initiated Date
    2006-04-06
  • Event Date Posted
    2006-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45292
  • 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
    manometric catheter - Product Code KLA
  • Reason
    Mislabeling- the 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. the correct port configuration is sequentially 1 through 8, from the distal to the proximal end of the catheter.
  • Action
    Recall initiated to International accounts on 04/05/06 and within US on 04/06/06 via an Urgent Recall Notification. The letter informs them of the manufacturing defect, requests return for credit of any unused inventory and requests accounting of all previously used catheters. Distributors are instructed to sent a letter to their customers to request product return.

Device

Zinetics Manometric catheter
  • Model / Serial
    Lots 0001391 and 0001464
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-including states of IL, NC, NY. and countries of Austria, Chile, Finland, Germany, Greece, Hong Kong, Italy, Japan, Lebanon, Norway, Peru, Portugal, Saudi Arabi, Spain
  • Product Description
    Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. 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