Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 25, 2016
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
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Monteris Medical Corp recalled NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s S… - a critical-severity action.
NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s S… was recalled by Monteris Medical Corp in May 25, 2016. Reason: Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with re…. Check the official notice for the remedy. Verify recall #Z-1614-2016 with the FDA Devices before acting.
The recall
Monteris Medical Corp issued this critical-severity FDA Devices recall-Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with re….
- Critical
- severity level
- 121 units
- affected scope
- Class I
- classification
- May 25, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1614-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 121.
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
121
Related Recalls
6
3 from same agency
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.
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 |
| Firm location | Plymouth, MN |
| Affected scope | 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1614-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 25, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.