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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used in neurosurgery where an unanticipated interaction with MRI systems poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
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