Events

Recall of Device Recall Percutaneous Trial Lead Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Jude Medical, 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
    69025
  • Event Risk Class
    Class 2
  • Event Number
    Z-2719-2014
  • Event Initiated Date
    2014-07-29
  • Event Date Posted
    2014-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129366
  • 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
    Stimulator, spinal-cord, implanted (pain relief) - Product Code GZB
  • Reason
    The directions for use (dfu) manual contains information for devices that are not approved in the us. the correct us approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
  • Action
    A field action was initiated with customer letters, dated July 29, 2014, and attached replacement DFUs. The letter identified the affected product and the reason for the recall. The recalling firm requested the consignees refer to the replacement DFU for guidance while using the device, and to discard the international manuals. Questions regarding the letter should be directed to customers' St. Jude Neuromodulation Representative or call the Technical Services Department at 1-800-727-7846.

Device

Device Recall Percutaneous Trial Lead Kits
  • Model / Serial
    Material 100077108, Batch 4519182
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of Texas and Illinois.
  • Product Description
    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). || Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
  • Manufacturer
    St. Jude Medical, Inc.

Manufacturer

St. Jude Medical, Inc.
  • Manufacturer Address
    St. Jude Medical, Inc., 6901 Preston Rd, Plano TX 75024-2508
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA