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Monteris Medical

Products: neuro-robot. Risk band: Elevated RobotRisk index 24.4/100 (severity- and time-weighted incidents) · ranked 11 of 25 among Medical robotics companies with incidents (173 tracked).

Analyst brief

Monteris Medical's record contains four entries spanning October 2014 to January 2019, all recalls, including two FDA Class I actions in 2016 and 2017 for the NeuroBlate System and its SideFire Select laser probe component, each rated severity 4. This is an entirely regulatory-driven record with no press-only incidents, and the recurrence of recalls against the same NeuroBlate laser-ablation platform across a five-year span indicates a repeated rather than isolated failure pattern concentrated in one product line. The presence of two Class I recalls — the FDA's highest-severity recall classification — is the dominant severity signature in this record. Monteris Medical's index of 24.4 ranks 11 of 25 companies in Medical robotics with incident history.

Risk index

24.4/100RobotRisk index

22.1/100Median index across the 25 Medical robotics companies with incident history (173 tracked, 148 with none)

11 of 25Rank in Medical robotics (of 25 with incident history)

ElevatedRisk band

Incident timeline

Comparisons over time

Per-type breakdown

Incident type	Unique incidents	Share
recall	4	100%

Unique incident list

4 unique incidents on file for this company.

Sev	Date	Type	Location	Incident	Source
S3	04 Jan 2019	recall	—	Monteris Medical had a serious recall	Medical Design & Outsour
S4	~Oct 2017	recall	—	FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for · MONTERIS MEDICAL NEUROBLATE SYSTEM, used for	openFDA enforcement
S4	25 Mar 2016	recall	—	FDA Class I recall: NeuroBlate System SideFire Select · NeuroBlate System SideFire Select	openFDA enforcement
S3	03 Oct 2014	recall	—	FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF: · FullFire Diffusing Tip Laser Probe, REF:	openFDA enforcement