Class II — Monteris Medical Corp
| Recalling firm | Monteris Medical Corp |
|---|---|
| Registered facility | MONTERIS MEDICAL CORP (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. |
| Product | SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone. |
| Quantity | 234 devices |
| Distribution | US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA |
| Initiated | 2014-10-03 |
| Classified | 2014-11-19 |
| Terminated | 2014-12-08 |
| Recall number | Z-0227-2015 |
| 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 II recall — Monteris Medical Corp (Z-0227-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69514/
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