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Monteris Medical Recalls
4 recalls on record · November 26, 2014 to March 28, 2018 · Medical Devices
Recalls by year
14
16
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 28, 2018Medical DevicesFDA
Monteris Medical Corp recalls MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Hazard: The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
May 25, 2016Medical DevicesFDA
Monteris Medical Corp recalls NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01,
Hazard: 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.
November 26, 2014Medical DevicesFDA
Monteris Medical Corp recalls FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are
Hazard: Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
November 26, 2014Medical DevicesFDA
Monteris Medical Corp recalls SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are p
Hazard: Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.