Events

Recall of Device Recall Medtronic SPECIFY

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
    48705
  • Event Risk Class
    Class 2
  • Event Number
    Z-2241-2008
  • Event Initiated Date
    2008-05-21
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71931
  • 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
    Lead kit for implanted spinal-cord stimulator (pain relief) - Product Code GZB
  • Reason
    Medtronic is recalling certain lots of model 3998 specify surgical lead kits due to a package mislabeling issue. the package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm. recalled lots are to be returned for replacement or credit.
  • Action
    In May 2008, a Product Recall letter was issued to customers. Medtronic Field Representatives are to contact customers with consigned or unregistered sold product to remove it and return it to Medtronic. A Leave-Behind letter will be provided to customers, explaining the issue and the reason for removal of product. Recalled devices will be returned for replacement or credit. The Medtronic representative will complete and return a Reply Card, which documents the notification of the customer. If you have questions or comments, contact your Medtronic representative.

Device

Device Recall Medtronic SPECIFY
  • Model / Serial
    V004442, V004456, V004457, V004541, V004644, V005789, V005838, V005884, V005952, V006010, V006011, V006497, V006610, V006732, V006888, V006937, V007136, V007224, V007342, V007451, V007565, V007729, V007781, V007911, V008174, V008257, V008387, V008638, V008639, V008729, V008902, V009060, V009191, V009278, V009352, V009353, V009630, V010099, V010124, V010125, V010366, V010367, V010602, V010744, V010896, V011057, V011091, V011215, V011257, V011299, V011406, V011457, V011552, V011610, V011627, V011860, V011958, V011977, V012040, V012123, V012202, V012238, V012260, V012411, V012571, V012618, V012935, V013158, V013231, V013331, V013489, V013615, V013745, V013787, V013837, V013862, V014190, V014320, V014426, V014454, V014660, V014785, V015071, V015166, V015327, V015626, V016195, V016445, V016489, V017182, V017731, V017927, V019145, V019452, V019569, V019909, V020188, V020688, V020904, V021560, V021753, V022880, V023339, V023517, V025268, V025500, V025707, V026020, V026436, V027462, V027804, V028474, V029383, V029983, V030442, V031317, V032070, V032560, V034825, V034832, V035769, V036156, V036810, V036857, V038530, V041066, V041365, V042627, V043757, V043759, V044336, V044850, V045723, V047365, V050371, V052566, V053142, V054607, V056045, V057371, V060415, V062321, V068860, V069647, V077531, V080086, V082162, V084570, V086942, V090294, V091959, V095777, V102426
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US distribution only to: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY
  • Product Description
    Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

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