Events

Recall of Device Recall PADPRO ADULT Radiotranslucent Pad w/Medtronic connector

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

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
    37495
  • Event Risk Class
    Class 2
  • Event Number
    Z-0757-2007
  • Event Initiated Date
    2007-03-08
  • Event Date Posted
    2007-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50639
  • 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
    Defibrillation/Pacing/Cardioversion/Monitoring Electrodes - Product Code MLN
  • Reason
    Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. this error makes the product unusable. the zoll and medtronic connectors are not interchangeable and are unique to their specific device.
  • Action
    On 3/08/07, "URGENT DEVICE RECALL" letters (dated 3/05/07) will be sent via UPS to the US distributors and direct user accounts. The letters inform them of the problem and of the recall. The letters instruct them to immediately discontinue using the affected lots, inspect their stocks, and to return them as soon as possible. The letters instruct the consignees to notify their customers of the recall of the devices to the user level if they have been distributed, and request the return of the products. Additionally, when requested, ConMed will notify distributor's customers (sub-accounts) by the same means. Returned devices will be automatically replaced by ConMed Corporation. A separate letter is being sent to the foreign accounts today instructing them to return the devices back to ConMed Corporation for final disposition. The letters also instruct the consignees to complete the accompanying reply form and fax it to Nancy Crisino at (315) 624-3089. ConMed has contracted Stericycle in Indianapolis, IN, to handle the recall and returns from the domestic accounts.

Device

Device Recall PADPRO ADULT Radiotranslucent Pad w/Medtronic connector
  • Model / Serial
    Lot Y101105-4
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Romania, Chile, and Belgium
  • Product Description
    PADPRO ADULT Radiotranslucent Pad w/Medtronic¿ connector, REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes. Made in USA for: CONMED CORPORATION Utica, New York, 13502.
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • Manufacturer Address
    Conmed Corporation, 525 French Road, Utica NY 13502-5945
  • Source
    USFDA