AccuDrain® INS8400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10381780023876), received between Dec 2, 2022 and Oct 31, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Fracture; Fracture

  A FACILITY REPORTED THAT THERE WAS LEAKAGE FROM THE ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE (INS8400) AT THE STOPCOCK LEVEL DURING USE. THE STOPCOCK DOES NOT CLOSE AS EXPEDITED AND SOME CSF LIQUID FLOWED THROUGH THE WHITE CATHETER CAP. THE CSF LIQUID FLOWING THROUGH THE WHITE CATHETER CAP PRESENTED RISK OF INFECTION AND RISK OF AIR BUBBLES. NO PATIENT INJURY WAS REPORTED. CUSTOMER IS NOT SURE OF THE LOT NUMBER OR DATE OF EVENT. POTENTIAL DATE OF EVENT: 9/10/2025 OR 9/24/2025. POTENTIAL LOT#: 7501181.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437438 ↗
• MalfunctionNov 27, 2024Complete Blockage; Complete Blockage

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20803064 ↗
• InjuryNov 27, 2024Complete Blockage; Complete Blockage

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 20803063 ↗
• MalfunctionNov 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 2648988-2024-00042 FOR THE ACCUDRAIN INS8400 BECAUSE THE CUSTOMER IS NOT SURE WHICH DEVICE WAS IN USE: A FACILITY REPORTED THAT EXTERNAL VENTRICULAR DRAIN (ACCUDRAIN INS8400) WAS PLACED AT THE BEDSIDE FOR IVH AND OBSTRUCTIVE HYDROCEPHALUS, AND SHORTLY THEREAFTER, BLOOD WAS NOTED TO BE LEAKING FROM THE DEVICE JUST AHEAD OF THE BURETTE. NURSING AND NEUROSURGERY ASSESSED THE DEVICE AND NOTED WHAT APPEARED TO BE A CRACK AT THE CONNECTION SITE. THE SYSTEM WAS REPLACED AND RECONNECTED TO THE PATIENT¿S EVD WITHOUT FURTHER LEAKING. THE PATIENT WAS STABLE AT THE TIME BUT SUBSEQUENTLY DIED. THE CUSTOMER REPORTED THAT THE PATIENT'S DEMISE IS UNRELATED TO THE DRAIN ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20763064 ↗
• MalfunctionDec 5, 2022Connection Problem; Connection Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920842 ↗
• InjuryDec 5, 2022Device Handling Problem; Device Handling Problem

  A FACILITY REPORTED THAT (B)(6) 2022, PATIENT WAS IMPLANTED WITH EXTERNAL DERIVATION SYSTEM AND EMBOLIZATION - ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE (INS8400) WAS USED. ON (B)(6) 2022, DURING CHANGE OF THE DRESSING, THE NURSE OBSERVED THAT THE DRAINAGE SYSTEM AND VENTRICULAR DRAIN/TAP WERE NOT YET CONNECTED, LEADING TO CSF LEAKAGE IN THE PATIENT'S BED. BRAIN SCAN WAS REALIZED IN EMERGENCY INDICATING HYDROCEPHALUS AND PNEUMOVENTRICULIA WITHIN THE FRONTAL HORN OF THE RIGHT VENTRICLE. THE DRAIN (OUTSIDE) WAS REMOVED, THE ORIFICE WAS CLOSED BY STITCH (FIXATION) UNDER SURGICAL ASEPSIS. NEW SURGERY WAS PERFORMED ON (B)(6) 2002 TO IMPLANT NEW DRAINAGE SYSTEM. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT IS STILL AT THE HOSPITAL. THERE WAS NEW IMPLANTATION OF DRAINAGE SYSTEM WITHOUT LIQUID WITH NO SIGN OF SIGN OF COMMITMENT (NO LIFE-THREATENING COMMITMENT). NOTHING NEW WAS UNCOVERED FROM THE MEDICAL EXAM.

  Patient problems: Hydrocephalus

  MAUDE report 15920735 ↗
• InjuryDec 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED THAT DURING THE TRANSFER FROM NEUROSURGICAL ICU TO NEUROSURGERY OPERATING ROOM, CSF WAS FOUND IN THE COLLECTION BAG OF THE ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE SYSTEM (INS8400). THE LIQUID WAS IN CONTACT WITH THE ANTI-BACTERIAL FILTER AT THE AIR INTAKE. THE UNIT COULD NOT BE USED LONGER, AND THE DRAINAGE COULD NOT BE DONE CORRECTLY. THIS INCIDENT EXPOSED THE PATIENT TO RISK OF ACUTE HYDROCEPHALUS, INTRACRANIAL HYPERTENSION, POSSIBLE BRAIN DAMAGES OR DEATH. THE PATIENT UNDERWENT ANOTHER SURGERY FOR IMPLANT OF ANOTHER DRAINAGE SET.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 15910984 ↗
• InjuryDec 2, 2022Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  A PATIENT WAS TRANSFERRED FROM ICU DEPARTMENT DURING HOSPITALIZATION FOR EXTERNAL VENTICULAR BYPASS TEN CRANIOTOMY FOLLOWING CEREBROVASCULAR ACCIDENT OF THE POSTERIOR FOSSA. THE MEDICAL TEAM THEN DETECTED INTRACRANIAL HYPERTENSION (WITH HYPERTENSIVE CRISIS) WITH NON-PERMEABLE ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE SYSTEM (INS8400) SYSTEM. AT THE END OF THE TRANSFER, THE SYSTEM (INS8400) STAYED CLAMPED ON THE PROXIMAL SIDE. DURING THE TRANSFER THE SYSTEM WAS CLAMPED ON PROXIMAL AND DISTAL SIDES. THE NURSE INDICATED THEY EXPLAINED TO PARAMEDIC TEAM HOW THE SYSTEM FUNCTIONED AND HOW TO CLAMP THE TAPS. THE MEDICAL TEAM REMOVED THE DRAINAGE SYSTEM THE DAY AFTER. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL IN THE HOSPITAL MAKING IT DIFFICULT TO EVALUATE NEUROLOGICAL CONSEQUENCES FOLLOWING THIS DYSFUNCTION.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 15910912 ↗