Exact FDA event identifier

Event 69514

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 03, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Monteris Medical Corp

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-0227-2015

Recall number: Z-0227-2015
Initiated: October 03, 2014
Classification: Class II
Status: Terminated
Recalling firm: Monteris Medical Corp
Quantity: 234 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.

Distribution pattern

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

device · product 2 of 2

FullFire Diffusing Tip Laser Probe, REF: DTP101-01, 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.

Z-0228-2015

Recall number: Z-0228-2015
Initiated: October 03, 2014
Classification: Class II
Status: Terminated
Recalling firm: Monteris Medical Corp
Quantity: 133 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

serial numbers: 20414-1-C1274-03, 20414-1-C1274-04, 20414-1-C1274-06, 20414-1-C1274-07, 20414-1-C1274-08, 20414-1-C1274-09, 20414-1-C1274-11, 20414-1-C1274-12, 20414-1-C1274-13, 20414-1-C1274-17, 20414-1-C1274-19, 20414-1-C1274-20, 20414-1-C1367-01, 20414-1-C1367-02, 20414-1-C1367-04, 20414-1-C1367-05, 20414-1-C1367-06, 20414-1-C1367-07, 20414-1-C3302-02, 20414-1-C3302-05, 20414-1-C3302-08, 20414-1-C3302-10, 20414-1-C3302-12, 20414-1-C3302-13, 20414-1-C3302-14, 20414-1-C3302-15, 20414-1-C3302-16, 20414-1-C3302-17, 20414-1-C3502-01, 20414-1-C3502-02, 20414-1-C3502-03, 20414-1-C3502-05, 20414-1-C3502-06, 20414-1-C3502-07, 20414-1-C3502-08, 20414-1-C3502-09, 20414-1-C3502-10, 20414-1-C3502-11, 20414-1-C3502-12, 20414-1-C3502-13, 20414-1-C3502-14, 20414-1-C3502-15, 20414-1-C3502-16, 20414-1-C3502-17, 20414-2-C1275-01, 20414-2-C1275-02, 20414-2-C1275-03, 20414-2-C1275-04, 20414-2-C1275-05, 20414-2-C1275-06, 20414-2-C1275-07, 20414-2-C1275-08, 20414-2-C1275-09, 20414-2-C1275-11, 20414-2-C1275-12, 20414-2-C1275-13, 20414-2-C1275-15, 20414-2-C1275-16, 20414-2-C1275-17, 20414-2-C1275-18, 20414-2-C1275-19, 20414-2-C1275-20, 20414-2-C1404-01, 20414-2-C1404-02, 20414-2-C1404-03, 20414-2-C1404-04, 20414-2-C1404-06, 20414-2-C1404-07, 20414-2-C1404-08, 20414-2-C1431-08, 20414-3-C1277-01, 20414-3-C1277-02, 20414-3-C1277-03, 20414-3-C1277-04, 20414-3-C1277-05, 20414-3-C1277-06, 20414-3-C1277-07, 20414-3-C1277-08, 20414-3-C1277-09, 20414-3-C1277-10, 20414-3-C3154-01, 20414-3-C3154-02, 20414-3-C3154-03, 20414-3-C3154-04, 20414-3-C3154-05, 20414-3-C3154-06, 20414-3-C3154-08, 20414-3-C3154-09, 20414-3-C3154-10, 20414-3-C3154-11, 20414-3-C3154-12, 20414-3-C3154-13, 20414-3-C3154-14, 20414-3-C3154-15, 20414-3-C3154-16, 20414-3-C3154-17, 20414-3-C3154-18, 20414-3-C3154-19, 20414-3-C3309-01, 20414-3-C3309-03, 20414-3-C3309-05, 20414-3-C3442-01, 20414-3-C3442-02, 20414-4-C1278-01, 20414-4-C1278-02, 20414-4-C1278-03, 20414-4-C1278-04, 20414-4-C1278-05, 20414-4-C1278-06, 20414-4-C1278-07, 20414-4-C1278-08, 20414-4-C1278-09, 20414-4-C1278-10, 20414-4-C1278-11, 20414-4-C1278-12, 20414-4-C1278-13, 20414-4-C3315-01, 20414-4-C3315-04, 20414-4-C3315-05, 20414-4-C3315-06, 20414-4-C3315-07, 20414-4-C3315-08, 20414-4-C3315-09, 20414-4-C3433-01, 20414-4-C3433-02, 20414-4-C3433-03, 20414-4-C3433-04, 20414-4-C3433-05, 20414-5-C1279-10, 20414-5-C1279-14, 20414-5-C1279-15, 20414-5-C3322-01, 20414-5-C3322-02.

Distribution pattern

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