Class I — Monteris Medical Corp
| Recalling firm | Monteris Medical Corp |
|---|---|
| Registered facility | MONTERIS MEDICAL CORP (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| Product | NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies … |
| Quantity | 121 |
| Distribution | Nationwide Distribution in the states of KS, MO, NC, OH, and VA. |
| Initiated | 2016-03-25 |
| Classified | 2016-05-16 |
| Terminated | 2017-03-10 |
| Recall number | Z-1614-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Monteris Medical Corp (Z-1614-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73849/
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