The Recall Desk

FDA (Devices) recall action 69514

Monteris Medical Corp recalled 2 products on 2014-11-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-11-26
Critical
0
Units
367

Why these products were recalled

Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-11-26

    Monteris Medical Recalls SideFire Directional Laser Probes Due to Tip Separation

    Monteris Medical is recalling 234 SideFire Directional Laser Probes because the distal sapphire tip may separate from the probe.

    Product
    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therap
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2014-11-26

    Monteris Medical Recalls FullFire Diffusing Tip Laser Probes Due to Tip Separation

    Monteris Medical is recalling 133 FullFire Diffusing Tip Laser Probes because the distal sapphire tip may separate from the probe.

    Product
    FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal ther
    Category
    Distribution
    12 states