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# Monteris Medical Recalls NeuroBlate System
- URL: https://www.fdaweb.com/monteris-medical-recalls-neuroblate-system/
- Published: 2018-03-22T12:00:00.000Z
- Updated: 2026-09-14T23:54:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141044

Unexpected heating of laser delivery probes has led to a Monteris Medical recall of its NeuroBlate system and laser delivery probes. The system is used during brain surgery to ablate, coagulate, or necrotize brain tissue cells. The recall covers 52 devices manufactured and distributed between 4/2013 and 7/2017\. FDA says the recall is Class 1.

An FDA recall [notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm602252.htm?ref=fdaweb.com) says that in some cases the laser delivery probes interact with the MRI system used to visualize the position of the catheter and cause unexpected heating and damage to the probe tip, which could cause unanticipated heating of surrounding brain tissue, or damage the tip of the probe, and allow the CO2 cooling gas inside the probe to leak into the brain.

An agency Dear Healthcare Provider [letter](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm602253.htm?ref=fdaweb.com) says that until Monteris identifies appropriate mitigation strategies and FDA has evaluated those strategies, the agency recommends that healthcare providers strongly consider treating patients using alternative procedures if available. Providers who do not believe there is a viable alternative should use the device with extreme caution, it says.