Reported Nov 26, 2014 · Terminated
SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are…
Monteris Medical Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Monteris Medical Corp · 16305 36th Ave N Suite 200 · Plymouth, MN · 55446-2884
Is this the product you have?
- SideFire Directional Laser Probe
- REFNBP101-01, 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
- Lot codes and dates
- serial numbers
234 of 234 codes
20368-1-C1112-0120368-1-C1112-0220368-1-C1112-0320368-1-C1112-0420368-1-C1112-0520368-1-C1112-0620368-1-C1112-0720368-1-C1112-0820368-1-C1112-0920368-1-C3173-0220368-1-C3173-0320368-1-C3173-0420368-1-C3173-0520368-1-C3173-0620368-1-C3173-0720368-1-C3173-0820368-1-C3173-0920368-1-C3173-1020368-1-C3173-1120368-1-C3173-1220368-1-C3173-1320368-1-C3173-1420368-1-C3173-1520368-1-C3173-1620368-1-C3173-1720368-1-C3173-1820368-1-C3173-1920368-1-C3173-2020368-1-C3258-0120368-1-C3258-0220368-1-C3258-0420368-1-C3258-0520368-1-C3258-0620368-1-C3258-0720368-1-C3258-1220368-1-C3258-1320368-1-C3258-1420368-1-C3462-0120368-1-C3462-0220368-1-C3462-0320368-1-C3462-0420368-1-C3462-0520368-1-C3462-0620368-1-C3462-0720368-1-C3462-0820368-1-C3462-0920368-1-C3462-1020368-1-C3462-1120368-1-C3462-1220368-1-C3462-1320368-1-C3462-1420368-1-C3462-1620368-1-C3462-1720368-1-C3462-1820368-1-C3462-1920368-1-C3462-2220368-1-C3462-2420368-1-C3462-2520368-1-C3756-0120368-1-C3756-02
- serial numbers
- Amount recalled
- 234 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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