FDA Medical Device Recalls (openFDA)
Monteris Medical Corp: 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.
- Recall number
- Z-0227-2015
- Recalling firm
- Monteris Medical Corp
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-10-03
- Posted
- 2014-11-19
- Terminated
- 2014-12-08
- Reason
- Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
- Root cause
- Process control
- Action
- Monteris Medical sent an Urgent Advisory Notice of Product Recall letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by user: Our distribution records document that you were shipped products from the affected lots. Please check your inventory to confirm whether you have any stock affected by this notice. An acknowledgment form is included to assist you in the assessment of your inventory. Your Monteris Medical Sales Representative will be glad to assist you with this assessment. Once your inventory has been verified, please fax the form back to Monteris Medical at 763-253-4728.
- Quantity
- 234 devices
- Distribution
- US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K120561","K131955","K141983"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3009970070
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28