Events

Recall of LIFEPAK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Physio Control Corp.

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
    28737
  • Event Risk Class
    Class 2
  • Event Number
    Z-0938-04
  • Event Initiated Date
    2004-04-05
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32434
  • 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 display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.
  • Action
    Letters dated April 2004 were sent to customers on 4/6/04. The letter explains that a service representative will visit the customer and check the capacitor.

Device

LIFEPAK
  • Model / Serial
    Part numbers VLP12, UVLP12, EVLP12, DVLP12, AVLP12, and any of these may have five to eight digits after the base number.   Serial numbers can be obtained from the firm or FDA''s Seattle District Recall Coordinator
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed to hospitals and medical centers throughout the US. The firm also distributed units internationally.
  • Product Description
    LIFEPAK 12 defibrillator/monitor.
  • Manufacturer
    Medtronic Physio Control Corp

Manufacturer

Medtronic Physio Control Corp
  • Manufacturer Address
    Medtronic Physio Control Corp, 11811 Willows Rd NE, Redmond WA 98073
  • Source
    USFDA