Licox® IP1PRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780250319), received between Jun 2, 2023 and Jun 2, 2023 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Intracranial Pressure Increased1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING EVENT DETAILS WAS REPORTED: PATIENT WAS HOSPITALIZED DUE TO SEVERE HEAD TRAUMA WITH MULTIPLE HEMORRHAGIC COMPONENTS, FOLLOWING TO A FALL DOWN THE STAIRS ON (B)(6) 2023. IT WAS COMPLICATED BY INTRACRANIAL HYPERTENSION WHICH REQUIRED THE REINTRODUCTION OF A NEUROSEDATION ON (B)(6) 2023 (SENTENCE TO BE CLARIFIED BY THE CUSTOMER). MEDICAL TEAM DECIDED TO INITIATE NEUROMONITORING WITH PTIO2 INTRACRANIAL SENSOR IN ORDER TO OPTIMIZE NEUROREANIMATION. THE SENSOR WAS INSERTED ON (B)(6) 2023. THE INSERTION "WAS COMPLICATED BY A SUBDURAL HEMATOMA WITH INTRACRANIAL HYPERTENSION DURING PROCEDURE (SENTENCE TO BE CLARIFIED BY THE CUSTOMER). THE PROCEDURE WAS STOPPED AFTER THE PASSAGE OF CRANIAL VAULT DUE TO INTRACRANIAL HYPERTENSION, ABSENCE OF SENSOR IMPLANTATION, REALIZATION OF EMERGENCY BRAIN IMAGING. NEUROSURGERY WAS PERFORMED IN EMERGENCY TO EVACUATE THE SUBDURAL HEMATOMA AFTER DIAGNOSIS CONFIRMATION BY BRAIN IMAGING. INTRACRANIAL HYPERTENSION WAS TREATED BY MAXIMAL MEDICAL TREATMENT, BILATERAL REGRESSIVE MYDRIASIS AFTER SURGICAL PROCEDURE. RECURRENCE OF SUBDURAL HEMATOMA DURING THE NIGHT OF (B)(6) 2023 WAS DETECTED DUE TO INCREASE OF INTRACRANIAL PRESSURE. NEUROSURGEONS DECIDE
Patient problems: Intracranial Pressure Increased
MAUDE report 17052808 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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