IRRAflow® ICCU 020Recalls & reported problems
Clearpoint Neuro, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00868643000401), received between Dec 21, 2021 and Dec 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (1 report).
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
- Output Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2021Output Problem
OVERDRAINAGE DURING TREATMENT OF TRAUMATIC IPH RESULTED IN SECONDARY SUBDURAL HEMATOMA. DURING THE TREATMENT OF A TRAUMATIC IPH WITH VENTRICULAR EXTENSION USING THE IRRAFLOW SYSTEM, EXCESSIVE FLUID REMOVAL WAS OBSERVED, AND THE PATIENT DEVELOPED A SECONDARY SUBDURAL HEMATOMA, WHICH WAS POTENTIALLY CAUSED BY OVERDRAINAGE OF CSF FROM THE VENTRICLES. TREATMENT CONTINUED AS NORMAL WITH THE PATIENT'S NEUROLOGICAL EXAM CONTINUING TO IMPROVE FROM THE TIME THAT THE BLEED WAS FIRST OBSERVED. AT THE CONCLUSION OF TREATMENT, THE PATIENT WAS DISCHARGED HOME IN A NORMAL MANNER, AND NO ADDITIONAL PROCEDURES WERE REQUIRED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13056460 ↗
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- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
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- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
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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