Monteris Medical Recalls NeuroBlate Systems Due to MRI Interaction
Monteris Medical Corp is recalling 52 NeuroBlate systems used for MRI-guided neurosurgery due to an unanticipated interaction with 1.5 Tesla MRI systems.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems."
Plain-English summary
Monteris Medical Corp is recalling 52 units of the MONTERIS MEDICAL NEUROBLATE SYSTEM. This device is used for MRI-guided neurosurgical ablation. The recall covers all serial numbers of the affected systems.
The firm initiated the recall after receiving complaints regarding an unanticipated interaction between the NeuroBlate system and 1.5 Tesla (1.5T) MRI systems. The source text does not specify the nature of the interaction or report any specific injuries or illnesses.
The affected products were distributed nationwide in the United States and in Canada. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
- Manufacturer
- Monteris Medical Corp
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Monteris Medical Corp
See all →- CriticalMonteris Medical Recalls NeuroBlate Laser Probes Due to Lens Fracture
FDA (Devices) · 2016-05-25
- HighMonteris Medical Recalls SideFire Directional Laser Probes Due to Tip Separation
FDA (Devices) · 2014-11-26
- HighMonteris Medical Recalls FullFire Diffusing Tip Laser Probes Due to Tip Separation
FDA (Devices) · 2014-11-26
Same hazard · device interaction
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- SevereImpella RP Heart Pump Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- CriticalImpella RP Flex Devices Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- ModerateImpella 5.5 with SmartAssist Set: Potential Device Interaction During Coronary Interventions
FDA (Devices) · 2024-09-11
- HighImpella 5.5 Device Recalled for Missing Labeling on Catheter Interaction
FDA (Devices) · 2024-09-11
Similar recalls
- CriticalMonteris Medical Recalls NeuroBlate Laser Probes Due to Lens Fracture
FDA (Devices) · 2016-05-25
- HighPhilips MRI Systems Recalled Due to Incorrectly Installed Patient Table Floor Plate
FDA (Devices) · 2024-04-24
- HighMonteris Medical Recalls SideFire Directional Laser Probes Due to Tip Separation
FDA (Devices) · 2014-11-26
- HighPhilips Ingenia 1.5T MRI systems recalled for patient support table installation defect
FDA (Devices) · 2024-04-24
- HighMonteris Medical Recalls FullFire Diffusing Tip Laser Probes Due to Tip Separation
FDA (Devices) · 2014-11-26
- ModerateToshiba MRI Systems Recalled for LCD Monitor Backlight Failure
FDA (Devices) · 2013-04-17