BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-1614-2016 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1614-2016
    Event ID
    73849
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Monteris Medical Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 25, 2016
    Initiation Date
    March 25, 2016
    Classification Date
    May 16, 2016
    Termination Date
    March 10, 2017
    Address
    16305 36th Ave N Suite 200, N/A, Plymouth, MN, 55446-2884, United States

    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.

    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.

    Code Info

    All unexpired lots of these models are being removed from the market.

    Distribution

    Nationwide Distribution in the states of KS, MO, NC, OH, and VA.

    Quantity

    121