Events

Recall of standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Emergency Response Systems, Inc..

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
    33327
  • Event Risk Class
    Class 2
  • Event Number
    Z-0117-06
  • Event Initiated Date
    2005-09-02
  • Event Date Posted
    2005-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41933
  • 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
    Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
  • Reason
    Potential for voltage pins in connector of therapy cable to break.
  • Action
    On 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing,

Device

standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.
  • Model / Serial
    Standard Hard Paddles part number: 3006228-013 and below
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed worldwide.
  • Product Description
    standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.

Manufacturer

Medtronic Emergency Response Systems, Inc.
  • Manufacturer Address
    Medtronic Emergency Response Systems, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Source
    USFDA