FullFire Diffusing Tip Laser Probe — Class II medical device recall Z-0228-2015
Terminated recall by Monteris Medical Corp, reported 2014-11-26, distributed in CA, CT, FL, GA, KS, MN, MO, NC…. Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe
| Recall number | Z-0228-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Monteris Medical Corp, Plymouth, MN, United States |
| Recall initiated | 2014-10-03 |
| Classified | 2014-11-19 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2014-12-08 |
| Distributed | CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, VA |
| Quantity | 133 devices |
| 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 and 108 more |
| Model numbers | DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01 |
Product
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.
Reason for recall
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0228-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.