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U.S. Department of Health and Human Services

Class 1 Device Recall NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe

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  Class 1 Device Recall NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe see related information
Date Initiated by Firm March 25, 2016
Date Posted May 16, 2016
Recall Status1 Terminated 3 on March 10, 2017
Recall Number Z-1614-2016
Recall Event ID 73849
510(K)Number K143457  
Product Classification Powered laser surgical instrument - Product Code GEX
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 under MRI visualization. It also provides real-time thermographic analysis of selected MRI images. The laser delivery probes direct the laser energy to the proper treatment location.
Code Information All unexpired lots of these models are being removed from the market.
Recalling Firm/
Manufacturer		 Monteris Medical Corp
16305 36th Ave N Suite 200
Plymouth MN 55446-2884
For Additional Information Contact Ginger Glaser
763-253-4721
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 121
Distribution Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = MONTERIS MEDICAL, INC.
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