Events

Recall of Device Recall NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Monteris Medical 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
    73849
  • Event Risk Class
    Class 1
  • Event Number
    Z-1614-2016
  • Event Initiated Date
    2016-03-25
  • Event Date Posted
    2016-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145141
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Monteris received a report that the sapphire lens on a 2.2sf probe fractured during a litt procedure, with resulting introduction of c02 into the patient's brain.
  • Action
    Monteris Medical Corporation field personnel visited each consignee starting March 25, 2016 and April 1, 2016. The devices were physically removed from each site. Customers from whom the devices were removed will either receive a credit or receive replacements of other models of laser delivery probes.

Device

Device Recall NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe
  • Model / Serial
    All unexpired lots of these models are being removed from the market.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
  • Product Description
    NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. || NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It also provides real-time thermographic analysis of selected MRI images. The laser delivery probes direct the laser energy to the proper treatment location.
  • Manufacturer
    Monteris Medical Corp

Manufacturer

Monteris Medical Corp
  • Manufacturer Address
    Monteris Medical Corp, 16305 36th Ave N Suite 200, Plymouth MN 55446-2884
  • Manufacturer Parent Company (2017)
    Monteris Medical Corp
  • Source
    USFDA