AccuDrainRecalls & reported problems across all models
Integra Lifesciences Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 3 models of AccuDrain by Integra Lifesciences Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2022 and Aug 6, 2026 — classified as 10 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AccuDrain problems
Device problems
- Fluid/Blood Leak7
- Break4
- Fracture4
- Complete Blockage3
- Crack2
- Disconnection2
- Connection Problem1
- Device Fell1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Cerebrospinal Fluid Leakage6
- Insufficient Information2
- Bacterial Infection1
- Headache1
- High Blood Pressure/ Hypertension1
- Hydrocephalus1
- Pneumocephalus1
AccuDrain models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AccuDrain® INS8401Shunt, central nervous system and components14 reports
- AccuDrain® INS8400Shunt, central nervous system and components8 reports
- AccuDrain® SP0214Shunt, central nervous system and components1 report
Recent AccuDrain adverse event reports
The 15 most recent reports across all models, 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
MalfunctionNov 26, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
MalfunctionNov 20, 2025Fracture; Fracture
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 ↗InjuryApr 3, 2025Disconnection; Disconnection
MalfunctionNov 27, 2024Complete Blockage; Complete Blockage
MalfunctionNov 27, 2024Complete Blockage; Complete Blockage
InjuryNov 27, 2024Complete Blockage; Complete Blockage
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 ↗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
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 ↗MalfunctionJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED THAT THE INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE (SP0214) WAS LEAKING AT THE STOPCOCK WHERE THE TRANSDUCER CONNECTS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE FOLLOWING: 1. WAS THE DEVICE USED IN A SURGERY? NO. 2. WAS REVISION/MEDICAL INTERVENTION REQUIRED? IF YES, WHAT REVISION/MEDICAL INTERVENTION WAS PERFORMED? CHANGED ACCUDRAIN AS SOON AS LEAKING NOTED. 3. HOW WAS THE PROCEDURE COMPLETED? STERILE FASHION. 4. COULD WE ASK HOW LONG WAS THE DEVICE IN SERVICE PRIOR NOTICING THE LEAK? (DEVICE PLACEMENT DATE?) MINUTES. LEAKING NOTICED IMMEDIATELY AFTER CONNECTING TO THE PATIENT. 5. ALSO, WHAT WAS OCCURRING AT THE TIME WHEN THE LEAK WAS OBSERVED? E.G., TRANSPORTING THE PATIENT, MOVING/TURNING THE PATIENT, ETC. NOTHING. - LEAKING IMMEDIATELY AFTER CONNECTION AT EVD PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590090 ↗
Other Integra Lifesciences Corporation products
All Integra Lifesciences Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page