Events

Recall of Medtronic DBS

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

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
    37847
  • Event Risk Class
    Class 2
  • Event Number
    Z-0934-2007
  • Event Initiated Date
    2007-04-16
  • Event Date Posted
    2007-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51935
  • 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
    Deep Brain Stimulation Lead Kit - Product Code MHY
  • Reason
    Mislabeling: the inner package labeling incorrectly specified the model number of the lead as 3387-40. the outer package labeling is correct and the package actually contains the correct lead (3389s-40).
  • Action
    Medtronic field personnel visited affected customers and retrieved product from this lot, unless the product was needed for an imminent scheduled surgery. Telephone scripts and leave behind letters to each consignee were initiated in April 2007.

Device

Medtronic DBS
  • Model / Serial
    V026775
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide including states of CA, CO, IL, IN, MD, NC, OH, PA, and WV.
  • Product Description
    Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Manufacturer Address
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA