Events

Recall of Covidien MediTrace Cadence Pediatric Radiotransparent Defibrillation Electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien LLC.

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
    64868
  • Event Risk Class
    Class 2
  • Event Number
    Z-1185-2013
  • Event Initiated Date
    2013-04-08
  • Event Date Posted
    2013-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117215
  • 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
    Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
  • Reason
    Defibrillation electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient.
  • Action
    Covidien sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 8, 2013 to all affected customers. The letter identifies the product, problem and requests that customers immediately stop using and segregate any affected product from inventory. Questions:Call 1-800-962-9888 option 8, then extension 2500.

Device

Covidien MediTrace Cadence Pediatric Radiotransparent Defibrillation Electrode
  • Model / Serial
    Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
  • Product Description
    Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode || Product ID: 22550P. || Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Manufacturer Address
    Covidien LLC, 15 Hampshire Street, Mansfield MA 02048-1113
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA