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SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. T...

FDA Device Recall #Z-0227-2015 — Class II — October 3, 2014

Recall Summary

Recall Number Z-0227-2015
Classification Class II — Moderate risk
Date Initiated October 3, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Monteris Medical Corp
Location Plymouth, MN
Product Type Devices
Quantity 234 devices

Product Description

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.

Reason for Recall

Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

Distribution Pattern

US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA

Lot / Code Information

serial numbers: 20368-1-C1112-01, 20368-1-C1112-02, 20368-1-C1112-03, 20368-1-C1112-04, 20368-1-C1112-05, 20368-1-C1112-06, 20368-1-C1112-07, 20368-1-C1112-08, 20368-1-C1112-09, 20368-1-C3173-02, 20368-1-C3173-03, 20368-1-C3173-04, 20368-1-C3173-05, 20368-1-C3173-06, 20368-1-C3173-07, 20368-1-C3173-08, 20368-1-C3173-09, 20368-1-C3173-10, 20368-1-C3173-11, 20368-1-C3173-12, 20368-1-C3173-13, 20368-1-C3173-14, 20368-1-C3173-15, 20368-1-C3173-16, 20368-1-C3173-17, 20368-1-C3173-18, 20368-1-C3173-19, 20368-1-C3173-20, 20368-1-C3258-01, 20368-1-C3258-02, 20368-1-C3258-04, 20368-1-C3258-05, 20368-1-C3258-06, 20368-1-C3258-07, 20368-1-C3258-12, 20368-1-C3258-13, 20368-1-C3258-14, 20368-1-C3462-01, 20368-1-C3462-02, 20368-1-C3462-03, 20368-1-C3462-04, 20368-1-C3462-05, 20368-1-C3462-06, 20368-1-C3462-07, 20368-1-C3462-08, 20368-1-C3462-09, 20368-1-C3462-10, 20368-1-C3462-11, 20368-1-C3462-12, 20368-1-C3462-13, 20368-1-C3462-14, 20368-1-C3462-16, 20368-1-C3462-17, 20368-1-C3462-18, 20368-1-C3462-19, 20368-1-C3462-22, 20368-1-C3462-24, 20368-1-C3462-25, 20368-1-C3756-01, 20368-1-C3756-02, 20368-1-C3756-04, 20368-1-C3756-05, 20368-1-C3756-06, 20368-1-C3756-07, 20368-1-C3756-08, 20368-1-C3756-11, 20368-1-C3756-12, 20368-2-C1276-02, 20368-2-C1276-04, 20368-2-C1276-05, 20368-2-C1276-06, 20368-2-C1276-07, 20368-2-C1276-08, 20368-2-C1276-09, 20368-2-C1276-11, 20368-2-C1276-12, 20368-2-C1276-13, 20368-2-C1276-14, 20368-2-C1276-15, 20368-2-C1276-16, 20368-2-C1276-17, 20368-2-C1276-18, 20368-2-C1276-19, 20368-2-C1276-20, 20368-2-C1276-21, 20368-2-C1276-22, 20368-2-C3287-01, 20368-2-C3287-02, 20368-2-C3287-03, 20368-2-C3287-04, 20368-2-C3287-05, 20368-2-C3287-06, 20368-2-C3287-07, 20368-2-C3287-08, 20368-2-C3287-09, 20368-2-C3287-10, 20368-2-C3287-11, 20368-2-C3287-12, 20368-2-C3287-13, 20368-2-C3287-14, 20368-2-C3287-15, 20368-2-C3287-16, 20368-2-C3287-17, 20368-2-C3287-19, 20368-2-C3287-20, 20368-2-C3287-21, 20368-2-C3287-22, 20368-2-C3472-01, 20368-2-C3472-02, 20368-2-C3472-03, 20368-2-C3472-04, 20368-2-C3472-05, 20368-2-C3472-06, 20368-2-C3472-07, 20368-2-C3472-08, 20368-2-C3472-09, 20368-2-C3472-10, 20368-2-C3472-11, 20368-3-C1115-01, 20368-3-C1115-02, 20368-3-C1115-03, 20368-3-C1115-04, 20368-3-C1115-05, 20368-3-C1115-06, 20368-3-C1115-07, 20368-3-C1115-08, 20368-3-C1115-09, 20368-3-C1115-10, 20368-3-C1116-01, 20368-3-C1116-02, 20368-3-C1116-04, 20368-3-C1116-05, 20368-3-C1116-06, 20368-3-C3293-01, 20368-3-C3293-02, 20368-3-C3293-03, 20368-3-C3293-04, 20368-3-C3293-05, 20368-3-C3293-07, 20368-3-C3293-10, 20368-3-C3293-11, 20368-3-C3293-13, 20368-3-C3293-14, 20368-3-C3293-15, 20368-3-C3293-16, 20368-3-C3293-17, 20368-3-C3293-19, 20368-3-C3293-20, 20368-3-C3293-21, 20368-3-C3293-23, 20368-3-C3452-04, 20368-3-C3452-06, 20368-3-C3452-07, 20368-3-C3452-09, 20368-3-C3452-10, 20368-3-C3452-11, 20368-3-C3452-13, 20368-3-C3452-14, 20368-3-C3452-15, 20368-3-C3452-17, 20368-3-C3452-18, 20368-3-C3452-20, 20368-3-C3452-21, 20368-3-C3452-22, 20368-3-C3452-24, 20368-3-C3452-25, 20368-3-C3512-01, 20368-3-C3512-02, 20368-3-C3512-03, 20368-3-C3512-04, 20368-3-C3512-05, 20368-3-C3512-06, 20368-3-C3512-08, 20368-4-C1117-01, 20368-4-C1117-02, 20368-4-C1117-03, 20368-4-C1117-05, 20368-4-C1117-06, 20368-4-C1117-08, 20368-4-C1117-09, 20368-4-C1117-10, 20368-4-C3166-01, 20368-4-C3166-02, 20368-4-C3166-03, 20368-4-C3166-04, 20368-4-C3166-05, 20368-4-C3166-06, 20368-4-C3166-07, 20368-4-C3166-08, 20368-4-C3166-09, 20368-4-C3166-10, 20368-4-C3166-12, 20368-4-C3166-13, 20368-4-C3166-14, 20368-4-C3166-15, 20368-4-C3166-16, 20368-4-C3166-17, 20368-4-C3166-18, 20368-4-C3166-19, 20368-4-C3166-20, 20368-4-C3264-01, 20368-4-C3264-02, 20368-4-C3264-03, 20368-4-C3264-04, 20368-4-C3264-06, 20368-4-C3264-08, 20368-4-C3264-09, 20368-4-C3264-10, 20368-4-C3264-12, 20368-4-C3264-14, 20368-4-C3264-15, 20368-4-C3264-16, 20368-4-C3264-17, 20368-4-C3264-18, 20368-4-C3264-19, 20368-4-C3264-21, 20368-4-C3264-22, 20368-4-C3264-24, 20368-4-C3264-25, 20368-5-C1118-03, 20368-5-C1118-04, 20368-5-C1118-05, 20368-5-C3298-03, 20368-5-C3298-04, 20368-5-C3298-05, 20368-5-C3298-06, 20368-5-C3298-07, 20368-5-C3298-08, 20368-5-C3298-09, 20368-5-C3298-10, 20368-5-C3798-01, 20368-5-C3798-02, 20368-5-C3798-21, 20368-5-C3798-22.

Other Recalls from Monteris Medical Corp

Recall # Classification Product Date
Z-0194-2018 Class I MONTERIS MEDICAL NEUROBLATE SYSTEM, used for M... Oct 5, 2017
Z-1614-2016 Class I NeuroBlate System SideFire Select 2.2 mm Direc... Mar 25, 2016
Z-0228-2015 Class II FullFire Diffusing Tip Laser Probe, REF: DTP10... Oct 3, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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