Severity
Critical
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 laser
Reported: May 25, 2016 Initiated: March 25, 2016 #Z-1614-2016 121 units
Monteris Medical Corp issued this FDA Devices recall on May 25, 2016. Classified as Critical severity (Class I). Approximately 121 units are affected. The recall was issued because: Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting in…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1614-2016) was formally reported on May 25, 2016, with the manufacturer initiating the action on March 25, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Monteris Medical Corp is listed as the recalling firm, operating out of Plymouth, MN. Federal records indicate 121 units are affected.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide Distribution in the states of KS, MO, NC, OH, and VA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
121
Related Recalls
6
6 from same agency
Recall Progress (industry avg ~60%) 60.0%
Product Description
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.
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.
Details
- Recalling Firm
- Monteris Medical Corp
- Units Affected
- 121
- Distribution
- Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
- Location
- Plymouth, MN
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1614-2016 |
| Date reported | May 25, 2016 |
| Date initiated | March 25, 2016 |
| Recalling firm | Monteris Medical Corp |
| Units affected | 121 |
| Distribution | Nationwide Distribution in the states of KS, MO, NC, OH, and VA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Monteris Medical Corp. Units affected: 121.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2016. Severity: Critical. Recall number: Z-1614-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution in the states of KS, MO, NC, OH, and VA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1614-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).