Reported Nov 26, 2014 · Terminated
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. 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?
- FullFire Diffusing Tip Laser Probe
- REFDTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. 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
133 of 133 codes
20414-1-C1274-0320414-1-C1274-0420414-1-C1274-0620414-1-C1274-0720414-1-C1274-0820414-1-C1274-0920414-1-C1274-1120414-1-C1274-1220414-1-C1274-1320414-1-C1274-1720414-1-C1274-1920414-1-C1274-2020414-1-C1367-0120414-1-C1367-0220414-1-C1367-0420414-1-C1367-0520414-1-C1367-0620414-1-C1367-0720414-1-C3302-0220414-1-C3302-0520414-1-C3302-0820414-1-C3302-1020414-1-C3302-1220414-1-C3302-1320414-1-C3302-1420414-1-C3302-1520414-1-C3302-1620414-1-C3302-1720414-1-C3502-0120414-1-C3502-0220414-1-C3502-0320414-1-C3502-0520414-1-C3502-0620414-1-C3502-0720414-1-C3502-0820414-1-C3502-0920414-1-C3502-1020414-1-C3502-1120414-1-C3502-1220414-1-C3502-1320414-1-C3502-1420414-1-C3502-1520414-1-C3502-1620414-1-C3502-1720414-2-C1275-0120414-2-C1275-0220414-2-C1275-0320414-2-C1275-0420414-2-C1275-0520414-2-C1275-0620414-2-C1275-0720414-2-C1275-0820414-2-C1275-0920414-2-C1275-1120414-2-C1275-1220414-2-C1275-1320414-2-C1275-1520414-2-C1275-1620414-2-C1275-1720414-2-C1275-18
- serial numbers
- Amount recalled
- 133 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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