Recall Z-1614-2016 ยท GEX Powered Laser Surgical Instrument
Monteris Medical Corp
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 irradiat
| Date | May 16, 2016 (initiated Mar 25, 2016) |
| 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. |
| Root cause | Device Design |
| Action | Monteris Medical Corporation field personnel visited each consignee starting March 25, 2016 and April 1, 2016. The devices were physically removed from each site. Customers from whom the devices were removed will either receive a credit or receive replacements of other models of laser delivery probes. |
| Quantity | 121 |
| Distribution | Nationwide Distribution in the states of KS, MO, NC, OH, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143457 | NeuroBlate System Monteris Medical, Inc., Feb 19, 2015 |