Facility

Synaptive Medical Inc

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

Key facts

4recalls · worst Class I

1inspections · 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)	3012075008
Establishment type	Manufacture Medical Device
Location	5055 Satellite Drive Mississauga Ontario, CA L4W 5K7
Registration status	Active · expires 2026
Parent company	Synaptive Medical Inc (owner-operator 10046804)
Brand names	BrightMatter Guide

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Neurological Stereotaxic Instrument
Product code HAW (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560

Recalls & enforcement

Class IITerminated2021-04-23
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
Class IITerminated2020-02-26
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Class ITerminated2018-10-09
This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered…
Class IITerminated2015-12-04
Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.

FDA inspections (1)

VAI2025-01-23
Voluntary Action Indicated · Compliance: 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 Synaptive Medical Inc

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. “Synaptive Medical Inc (FEI 3012075008) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012075008-synaptive-medical-inc/

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