Products: neuro-robot. Risk band: Low RobotRisk index 14.6/100 (incidents/exposure, time-weighted) · 92th percentile of 162 medical robotics companies.
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 14.8 is markedly higher than the other entities in this set, yet its 92.5 percentile places it in the low-risk band within medical-robotics, indicating the category's peer distribution carries comparably or more severe records.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 01/04 2019 |
recall | — | Monteris Medical had a serious recall | Medical Design & Outsour |
| S4 | 10/2017 | recall | — | FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for · MONTERIS MEDICAL NEUROBLATE SYSTEM, us… | openFDA enforcement |
| S4 | 03/25 2016 |
recall | — | FDA Class I recall: NeuroBlate System SideFire Select · NeuroBlate System SideFire Select | openFDA enforcement |
| S3 | 10/03 2014 |
recall | — | FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF: · FullFire Diffusing Tip Laser Probe, RE… | openFDA enforcement |