Events

Recall of Device Recall LIFEPAK 12

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
    30915
  • Event Risk Class
    Class 2
  • Event Number
    Z-0495-05
  • Event Initiated Date
    2005-01-15
  • Event Date Posted
    2005-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36800
  • 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
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    The lifepak 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
  • Action
    The firm sent 4000 User Notification letters via FED-EX on 1/15/2005 and approximately 3000 on 1/17/2005. The User Notification letters informed consignees about the two complaints and described the firm''s findings from their investigation into the problem. The letters also requested the users check the default energy settings; report back to the firm any discrepancies found; and reset the discrepant settings which differed from the user programmed settings.

Device

Device Recall LIFEPAK 12
  • Model / Serial
    VLP12-02 Part Numbers all with a Biphasic label on the front of the device
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    28,835 devices were shipped to 6874 domestic consignees.
  • Product Description
    LIFEPAK 12 defibrillator/ monitors biphasic
  • 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