Recall of Device Recall Neurotherm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neurotherm, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Probe, radiofrequency lesion - Product Code GXI
  • Reason
    Straight needle labeled as a curved needle.
  • Action
    NeuroTherm notified consignees by telephone between February 2- March 15, 2013 about the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return devices.


  • Model / Serial
    Lot number: 12131-1C
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Nationwide Distribution in the states of CA ,CO, OH, OR
  • Product Description
    Neurotherm Curved Radiofrequency (RF) cannnula 10 cm || 18 gauge, 10 mm active tip || Model Number: C-1010-R-18 || Product Usage: || The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.
  • Manufacturer


  • Manufacturer Address
    Neurotherm, Inc., 600 Research Dr Ste 1, Wilmington MA 01887-4438
  • Source