IRRAflow® 2.0 Catheter ICGS 020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00868643000432), received between Dec 21, 2021 and Feb 8, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2023Gas/Air Leak; Gas/Air Leak

  A COMPLAINT WAS RECEIVED FROM MT. SINAI WEST HOSPITAL OF TWO PATIENTS THAT SHOWED AN INCREASE IN PNEUMOCEPHALUS ON DAY 8 OF THE IRRAFLOW CATHETER AND CNS SYSTEM USE. IT IS BELIEVED THAT THE CLINICAL STAFF HAD PROPERLY PRIMED THE SYSTEM. NO ADDITIONAL DATA WERE PROVIDED FOR PATIENT ONE. THIS COMPLAINT IS FOR PATIENT 2, SEPARATED INTO 2 COMPLAINTS AT FDA'S REQUEST. DATA WERE ONLY PROVIDED FOR THE SECOND PATIENT. IT WAS NOTED THAT IN PATIENT TWO, THE IRRAFLOW CNS SYSTEM WAS THE ONLY DEVICE CURRENTLY BEING IN THE PATIENT'S TREATMENT. THE IRRAFLOW SYSTEM WAS BEING USED IN DRAIN MODE ONLY. PATIENT NUMBER TWO HAD CSF LEAK UNRELATED O THE CATHETER INSERTION ON DAY 7 OF TREATEMENT, WHERE THE CLINICAL STAFF ADDED SUTURINGTHE DEVICE FROM PATIENT TWO HAS BEEN REQUESTED TO BE RETURNED FOR ANALYSIS. THE PATIENT'S PNIUMOCEPHALUS IMPROVED, AND THE PATIENT REMAINED IN THE ICU DUE TO OTHER TREATMENT. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Pneumocephalus

  MAUDE report 16328455 ↗
• MalfunctionJan 10, 2023Material Integrity Problem; Material Integrity Problem

  "WE HAD A CATHTER LEAK IDENTIFIED TODAY. THE RESIDENT SWEARS THAT THE CATHETER COULDN'T HAVE BEEN HIT WITH THE NEEDLE AND THAT IT IS A SPONTANEOUS FAILURE. I THINK IT LIKELY WAS AN INCIDENTAL NEEDLE INJURY TO THE CATHETER. DO YOU MIND SHOWING THESE PICTURES TO THE ENGINEERS TO GET THEIR OPINION ON HOW LIKELY THIS IS TO BE A SPONTANEOUS FAILURE AND HAVE YOU HEARD OF THIS HAPPENING BEFORE? ALSO, DO YOU HAPPEN TO KNOW THE MODEL OF THE BOLD THAT BEHNAM USES? I THINK WE MIGHT LIKE TO TRY IT FOR A FEW IRRAFLOWS AND SEE IF WE LIKE THAT METHOD BETTER." THERE WAS NO IMPACT TO THE PATIENT'S TREATMENT, BUT THERE WAS A MINOR DELAY IN THERAPY. SUPPLEMENT CREATED AT FDA REQUEST TO DELETE TYPE OF REPORTABLE EVENT CHECKED BOX, AND DELETE NOE

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 16133928 ↗
• MalfunctionJan 10, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  HOLD FOR RH 2.3 THE PATIENT WAS DIAGNOSED WITH VENTRICULITIS AND WAS RECEIVING TREATMENT DUE TO THE VENTRICULITIS WITH THE IRRAFLOW SYSTEM. TREATMENT FROM THE IRRAFLOW SYSTEM BEGAN AT 11PM. THE FOLLOWING DAY, IRRAS REPRESENTATIVE AND NEUROCRITICAL CARE EDUCATOR, MS. (B)(4), WAS NOTIFIED FROM THE MEDICAL STAFF THAT THE PATIENT MAY BE RETAINING FLUID BECAUSE THERE WAS A FLUID IMBALANCE BETWEEN IRRIGATION AND DRAINAGE (NOT DUE TO PATIENT CONDITION). THE PATIENT WAS TAKEN TO CT SCAN AT APPROXIMATELY 12PM WHERE AIR WAS OBSERVED IN THE VENTRICLES AND DRAINAGE TUBE. THE STAFF INSPECTED THE CATHETER AND DISCOVERED A TEAR IN THE CATHETER. THERE WAS NO NOTED LEAKAGE FROM THE CATHETER PRIOR TO CT SCAN. THE FIELD FAILURE OF THE ICGS020 MAIN CATHETER BODY SIDE WALL OBSERVED ON (B)(6) 2022, 12 HOURS AFTER DEVICE PLACEMENT. AS OF (B)(6) 2022, ABBY JOHNSTON, IRRAS NEUROCRITICAL CARE EDUCATOR, REPORTED THAT THE PATIENT IS DOING GREAT UNDER IRRAFLOW TREATMENT. HER ASSESSMENT WAS THAT THE MANIPULATION WAS REQUIRED FOR THE NEW CATHETER REPLACEMENT. ATTEMPTS HAVE BEEN MADE TO SUBMIT THIS REPORT FOR SOME TIME. AS THE NEW HEAD OF RA FOR IRRAS, NEEDED TO OPEN AN ESG ACCT. AND WITH ESG HELPDESK SINCE (B)(6

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 16133909 ↗
• InjuryAug 24, 2022Gas/Air Leak; Gas/Air Leak

  A COMPLAINT WAS RECEIVED FROM MT. SINAI WEST HOSPITAL OF TWO PATIENTS THAT SHOWED AN INCREASE IN PNEUMOCEPHALUS ON DAY 8 OF THE IRRAFLOW CATHETER AND CNS SYSTEM USE. IT IS BELIEVED THAT THE CLINICAL STAFF HAD PROPERLY PRIMED THE SYSTEM. DATA WERE ONLY PROVIDED FOR THE SECOND PATIENT. IT WAS NOTED THAT IN PATIENT TWO, THE IRRAFLOW CNS SYSTEM WAS THE ONLY DEVICE CURRENTLY BEING IN THE PATIENT'S TREATMENT. THE IRRAFLOW SYSTEM WAS BEING USED IN DRAIN MODE ONLY. PATIENT NUMBER TWO HAD CSF LEAK UNRELATED O THE CATHETER INSERTION ON DAY 7 OF TREATMENT, WHERE THE CLINICAL STAFF ADDED SUTURING THE DEVICE FROM PATIENT TWO HAS BEEN REQUESTED TO BE RETURNED FOR ANALYSIS. THE PATIENT'S PNIUMOCEPHALUS IMPROVED, AND THE PATIENT REMAINED IN THE ICU DUE TO OTHER TREATMENT.

  Patient problems: Pneumocephalus

  MAUDE report 15285768 ↗
• MalfunctionAug 16, 2022Material Integrity Problem; Material Integrity Problem

  "WE HAD A CATHTER LEAK IDENTIFIED TODAY. THE RESIDENT SWEARS THAT THE CATHETER COULDN'T HAVE BEEN HIT WITH THE NEEDLE AND THAT IT IS A SPONTANEOUS FAILURE. I THINK IT LIKELY WAS AN INCIDENTAL NEEDLE INJURY TO THE CATHETER. DO YOU MIND SHOWING THESE PICTURES TO THE ENGINEERS TO GET THEIR OPINION ON HOW LIKELY THIS IS TO BE A SPONTANEOUS FAILURE AND HAVE YOU HEARD OF THIS HAPPENING BEFORE? ALSO, DO YOU HAPPEN TO KNOW THE MODEL OF THE BOLD THAT BEHNAM USES? I THINK WE MIGHT LIKE TO TRY IT FOR A FEW IRRAFLOWS AND SEE IF WE LIKE THAT METHOD BETTER." THERE WAS NO IMPACT TO THE PATIENT'S TREATMENT, BUT THERE WAS A MINOR DELAY IN THERAPY.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 15233311 ↗
• MalfunctionAug 15, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE PATIENT WAS DIAGNOSED WITH VENTRICULITIS AND WAS RECEIVING TREATMENT DUE TO THE VENTRICULITIS WITH THE IRRAFLOW SYSTEM. TREATMENT FROM THE IRRAFLOW SYSTEM BEGAN AT 11PM. THE FOLLOWING DAY, IRRAS REPRESENTATIVE AND NEUROCRITICAL CARE EDUCATOR, MS. JOHNSTON, WAS NOTIFIED FROM THE MEDICAL STAFF THAT THE PATIENT MAY BE RETAINING FLUID BECAUSE THERE WAS A FLUID IMBALANCE BETWEEN IRRIGATION AND DRAINAGE (NOT DUE TO PATIENT CONDITION). THE PATIENT WAS TAKEN TO CT SCAN AT APPROXIMATELY 12PM WHERE AIR WAS OBSERVED IN THE VENTRICLES AND DRAINAGE TUBE. THE STAFF INSPECTED THE CATHETER AND DISCOVERED A TEAR IN THE CATHETER. THERE WAS NO NOTED LEAKAGE FROM THE CATHETER PRIOR TO CT SCAN. THE FIELD FAILURE OF THE ICGS020 MAIN CATHETER BODY SIDE WALL OBSERVED ON (B)(6)2022, 12 HOURS AFTER DEVICE PLACEMENT. AS OF (B)(6)2022, ABBY JOHNSTON, IRRAS NEUROCRITICAL CARE EDUCATOR, REPORTED THAT THE PATIENT IS DOING GREAT UNDER IRRAFLOW TREATMENT. HER ASSESSMENT WAS THAT THE MANIPULATION WAS REQUIRED FOR THE NEW CATHETER REPLACEMENT. ATTEMPTS HAVE BEEN MADE TO SUBMIT THIS REPORT FOR SOME TIME. AS THE NEW HEAD OF RA FOR IRRAS, NEEDED TO OPEN AN ESG ACCT. AND WITH ESG HELPDESK SINCE (B)(6) 2022 TO GET AC

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 15228223 ↗
• MalfunctionDec 21, 2021Break; Fluid/Blood Leak

  IRRAFLOW CATHETER WAS PLACED IN PATIENT. NURSE NOTICED WATER LEAKAGE IN PATIENT'S BED AT PATIENT'S RIGHT ARM. TUBING AND STOPCOCK HAD BROKEN. CATHETER WAS PLACED IN OR BY DR. (B)(6) ON (B)(6) 2021. ON (B)(6) 2021, RN (B)(6) DISCOVERED THAT THERE WAS WATER IN THE BED BY THE PATIENT'S RIGHT ARM DURING THE BED BATH. ALSO, THE TUBING AND STOPCOK FELL APART AND THE WATER LEAKAGE MAY HAVE BEEN OCCURRING FOR SOME TIME. (B)(6) TOOK OFF THE BROKEN STOPCOCK AND DISCARDED IT. A CT SCAN OF THE PATIENT'S BRAIN SHOWED THAT THERE WAS AIR IN THE VENTRICLES. HOWEVER, THE PATIENT DID NOT NED A CATHETER REPLACEMENT.

  Patient problems: Air Embolism

  MAUDE report 13056388 ↗