Facility

MONTERIS MEDICAL CORP

3 recall(s) on record — most severe on record: Class I.

Key facts

3recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009970070
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	131 Cheshire Lane, Suite 100 Minnetonka, MN, US 55305
Registration status	Active · expires 2026
Parent company	Monteris Medical Corp (owner-operator 10042500)
Brand names	M Vision Software; NeuroBlate; M-Vision Pro Software

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (2)

Neurological Stereotaxic Instrument
Product code HAW (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560
Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class ITerminated2017-10-05
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Class ITerminated2016-03-25
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.
Class IITerminated2014-10-03
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

FDA inspections (2)

VAI2018-10-04
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2016-06-30
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Monteris Medical Corp

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MONTERIS MEDICAL CORP (FEI 3009970070) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009970070-monteris-medical-corp/

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