Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 26, 2014
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.
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Monteris Medical Corp recalled FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP… - a moderate-severity action.
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP… was recalled by Monteris Medical Corp in November 26, 2014. Reason: Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery prob…. Check the official notice for the remedy. Verify recall #Z-0228-2015 with the FDA Devices before acting.
The recall
Monteris Medical Corp issued this moderate-severity FDA Devices recall-Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery prob….
- Moderate
- severity level
- 133 units
- affected scope
- Class II
- classification
- November 26, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0228-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0228-2015) was formally reported on November 26, 2014, with the manufacturer initiating the action on October 3, 2014. It is classified under Moderate severity (Class II), 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 133 devices.
The documented reason for this recall is: Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. Distribution data in the federal record shows the product reached: US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
133 devices
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0228-2015 |
| Date reported | November 26, 2014 |
| Date initiated | October 3, 2014 |
| Recalling firm | Monteris Medical Corp |
| Firm location | Plymouth, MN |
| Affected scope | 133 devices |
| Distribution | US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, 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-0228-2015) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
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.. Recalled by Monteris Medical Corp. Units affected: 133 devices.
Why was this product recalled? ▼
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2014. Severity: Moderate. Recall number: Z-0228-2015.
Where was the recalled product distributed? ▼
Distribution: US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0228-2015) 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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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 November 26, 2014. 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.