AccuDrain® INS8401Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10381780023883), received between Jun 29, 2022 and Aug 6, 2026 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Crack; Fluid/Blood Leak

  A facility reported that the Accudrain device (catlog# unknown) was used on a patient to drain CSF, and the port closest to the head with the yellow cap was leaking; when they attempted to remove the cap, it cracked off. It was reported that there was no injury to the patient, but infection was noted. Additional information regarding the type of infection and any required intervention has been requested.

  Patient problems: Unspecified Infection

  MAUDE report 50161280 ↗
• MalfunctionApr 24, 2026Fracture; Device Fell

  MW5184806 WAS RECEIVED WITH THE FOLLOWING INFORMATION: "PLASTIC PART OF EXTERNAL VENTRICULAR DRAIN BROKE AND DEVICE FELL TO GROUND." ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED AS FOLLOWS: 1. TYPE OF EVENT SELECTED IN THE MEDWATCH IS "SERIOUS INJURY". PROVIDE DETAILS OF THE SERIOUS INJURY. ANSWER: THIS IS INCORRECT. THERE WAS NO INJURY. I AM SURE THE EVENT TYPE CHECKED WAS POTENTIALLY HARMFUL EVENT. THERE WAS NO HARM TO THE PATIENT. 2. PLEASE ADVISE THE TYPE OF PROCEDURE FOR WHICH ACCUDRAIN WAS USED. ANSWER: CSF DRAINAGE AFTER SUBDURAL BLEED. 3. WAS THERE CSF LEAKAGE DURING THE INCIDENT? ANSWER: NO 4. IF CSF LEAKED, HOW MUCH WAS IT (IF AN EXACT AMOUNT CANNOT BE PROVIDED, PLEASE PROVIDE AN APPROXIMATE: SMALL AMOUNT, MODERATE, ETC.) ANSWER: N/A 5. AFTER ACCUDRAIN BROKE AND FELL, WAS IT REPLACED WITH ANOTHER DEVICE? ANSWER: YES, ANOTHER ACCUDRAIN WAS ATTACHED. 6. WAS ANY MEDICAL INTERVENTION PERFORMED AS A RESULT OF THIS INCIDENT? ANSWER: NO 7. WAS THERE SIGNIFICANT DELAY TO TREATMENT? IF YES, HOW LONG WAS THE DELAY IN MINUTES? NO ANSWER GIVEN 8. DID THE PATIENT PRESENT WITH CLINICAL SIGNS AND SYMPTOMS, AND IF SO, WHAT WERE THEY? ANSWER: FROM THIS EVENT- NONE. FROM INITIAL INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984907 ↗
• InjuryMar 6, 2026Disconnection

  N/A.

  Patient problems: Cerebrospinal Fluid Leakage; Pneumocephalus

  MAUDE report 24539458 ↗
• MalfunctionNov 26, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23661521 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612276 ↗
• InjuryApr 3, 2025Disconnection; Disconnection

  N/A.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 21766209 ↗
• MalfunctionNov 27, 2024Complete Blockage; Complete Blockage

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20803221 ↗
• MalfunctionNov 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 2648988-2024-00041 FOR THE ACCUDRAIN INS8401 BECAUSE THE CUSTOMER IS NOT SURE WHICH DEVICE WAS IN USE: A FACILITY REPORTED THAT EXTERNAL VENTRICULAR DRAIN (ACCUDRAIN INS8401) 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 20758992 ↗
• MalfunctionOct 15, 2024Fracture; Fracture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452088 ↗
• MalfunctionSep 12, 2024Break; Break

  A FACILITY REPORTED THAT THE ACCUDRAIN WITH ANTI-REFLUX VALVE (INS8401) BROKE PROXIMAL TO THE PATIENT NEAR THE STOPCOCK. THE DRAIN DISCONNECTED AND FELL APART AT THE PATIENT CONNECTION. THERE WAS NO PATIENT INJURY OR DELAY IN TREATMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20204848 ↗
• InjuryMar 22, 2024Break; Break

  A FACILITY REPORTED THAT A PEDIATRIC PATIENT HAD AN ACCUDRAIN (INS8401) SINCE FEBRUARY 8, 2024, AND HAD BEEN ON THE MEDTRONIC DUET PRIOR TO THAT. THE LUER LOCK NEAR THE BAG FELL OFF DURING BAG REPLACEMENT YESTERDAY, AND A NEW ACCUDRAIN WAS PLACED. NO PATIENT INJURY HAS BEEN REPORTED; HOWEVER, THE PATIENT HAD A POSITIVE CEREBROSPINAL FLUID (CSF) CULTURE. THE DRAIN WAS PLACED BEDSIDE IN THE PICU AND IS NOT AVAILABLE AS IT WAS DISCARDED. ADDITIONAL INFORMATION RECEIVED FROM INTEGRA REPRESENTATIVE INDICATES THE FOLLOWING: -THE DRAIN WAS PURCHASED IN FEBRUARY AND THEN PLACED ON THE PATIENT AS SOON AS IN-SERVICE WAS DONE ON 2/8/2024. -THE DRAIN BROKE, AND THE REPORTING INTEGRA REPRESENTATIVE WAS INFORMED ON 2/20/2024. IT WAS ON THE PATIENT FOR QUITE SOME TIME. -THE STAFF IS USED TO A MEDTRONIC DRAIN WHICH HAS A LUER LOCK THAT TIGHTENS THE OPPOSITE DIRECTION FROM OUR ACCUDRAIN (IN RELATION TO THE DRAINAGE BAG REPLACEMENT). IT IS POSSIBLE IT WEAKENED FROM MULTIPLE ATTEMPTS TO LOOSEN IT (BUT IN THE WRONG DIRECTION). -THE BAG WAS REPLACED APPROXIMATELY EVERY OTHER DAY.

  Patient problems: Bacterial Infection

  MAUDE report 18960111 ↗
• MalfunctionApr 13, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  N/A.

  Patient problems: Cerebrospinal Fluid Leakage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738187 ↗
• InjuryMar 23, 2023Break; Break

  A FACILITY REPORTED THAT PATIENT WAS FOUND WITH A DISCONNECTED LUMBAR DRAIN AND A SIGNIFICANT AMOUNT OF CEREBROSPINAL FLUID (CSF) HAD DRAINED INTO THE BED. THE LUMBAR DRAIN DISCONNECTED AT A LOCATION THAT WAS NOT INTENDED TO DISCONNECT (NOT A STOPCOCK/CONNECTION). IT WAS LATER REPORTED THAT IT "LOOKS LIKE THE LUMBAR DRAIN TUBING WAS WELL ADHERED TO THE BACK OF THE PATIENT, SO NO DISLODGEMENT OCCURRED. THE LUMBAR TUBING BROKE AT THE PLACE WHERE THE SMALLER TUBING CONNECTS INSIDE THE LARGER BORE TUBING."

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 16603421 ↗
• InjuryJun 29, 2022Break; Break

  A FACILITY REPORTED THAT THE ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE (INS8400) WAS PLACED AT BEDSIDE AND USED FOR MULTIPLE DAY. SUBSEQUENTLY, THE COLLECTION BAG BROKE OFF AT THE BOTTOM OF THE COLLECTION CHAMBER AND EXPOSED THE PATIENT TO DIRECT AIR THROUGH THE BROKEN BOTTOM. IT ALSO SPILLED THE PATIENTS CEREBROSPINAL FLUID (CSF) ALL OVER THE FLOOR AND BED. THE PATIENT HAD TO HAVE A SECOND ACCUDRAIN EVD PLACED AT BEDSIDE. NO FURTHER ADVERSE CONSEQUENCE TO THE PATIENT OCCURRED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 14861471 ↗