Events

Recall of Device Recall Zinetics Reference pH 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
    34535
  • Event Risk Class
    Class 2
  • Event Number
    Z-0830-06
  • Event Initiated Date
    2006-01-25
  • Event Date Posted
    2006-05-03
  • 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=44031
  • 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
    Lot 0001491 has a manufacturing defect in the sensor spacing. sensors have been placed 5 cm apart instead of 15 cm apart. medtronic has determined that patient safety is not compromised. clinicians however should review and reassess the results of any patient studies for which catheters from lot 0001491 were used.
  • Action
    An Urgent Recall letter was issued to all affected customers 1/25/2006. This letter described the issue and listed what actions customers were to take to return affected product.

Device

Device Recall Zinetics Reference pH Catheter
  • Model / Serial
    Lot 0001491
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    within US only: MI, PA, TX
  • Product Description
    Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. 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