VentriClear G44130Recalls & reported problems
Cook Incorporated · VentriClear II Ventricular Drainage Catheter · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002441309), received between Apr 22, 2017 and Nov 12, 2025 — classified as 4 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Break” (5 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.
Reports received per month
Most reported problems
Device problems
- Break5
- Device Contaminated During Manufacture or Shipping2
- Fluid/Blood Leak2
- Flaked1
- Fracture1
- Hole In Material1
Patient problems
- No Code Available4
- No Known Impact Or Consequence To Patient3
- Cerebrospinal Fluid Leakage1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534015 ↗MalfunctionSep 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 10547141 ↗MalfunctionAug 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE LEAK WAS FROM THE SKIN EXIT SITE AND HAD NOTHING TO DO WITH THE CONNECTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10436810 ↗MalfunctionMay 6, 2020Flaked; Device Contaminated During Manufacture or Shipping; Flaked; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10028218 ↗MalfunctionMar 22, 2018Hole In Material; Hole In Material
IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) ATTEMPTED TO USE THE CATHETER BUT FOUND THAT IT WAS DEFECTIVE AS THERE WAS A HOLE IN THE SIDE OF IT. THE HCP WAS UNABLE TO USE THE DEVICE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED THE REPORTER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7364357 ↗MalfunctionFeb 27, 2018Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) ATTEMPTED TO USE THE CATHETER BUT FOUND THAT IT WAS DEFECTIVE AS THERE WAS A HOLE IN THE SIDE OF IT. THE HCP WAS UNABLE TO USE THE DEVICE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7300180 ↗InjuryMay 11, 2017Break; Break
A REPRESENTATIVE OF A SPINAL AND ORTHOPEDIC DEVICE MANUFACTURER REPORTED THAT A PHYSICIAN STATED THE VENTRICLEAR DRAINAGE CATHETER BROKE OFF DURING AN UNSPECIFIED PROCEDURE DURING INSERTION. ADDITIONAL INFORMATION WAS REQUESTED REGARDING RETRIEVAL OF THE DEVICE AND PATIENT OUTCOME; HOWEVER, AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE FROM THE INITIAL REPORTER. THE CONTACT INFORMATION FOR THE REPORTING PHYSICIAN, INCLUDING USER FACILITY INFORMATION IS NOT AVAILABLE. A STATEMENT THAT THIS EVENT OCCURRED MULTIPLE TIMES CANNOT BE VALIDATED. THERE IS NO FURTHER INFORMATION AVAILABLE AND THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6559714 ↗InjuryApr 22, 2017Break; Break
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PHYSICIAN STATED THE CATHETER BROKE OFF DURING A PROCEDURE DURING INSERTION. ACCORDING TO THE REPORT, THE CATHETER POPPED OFF/SNAPPED WHILE IN THE PATIENT DURING THE PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED PNEUMOCEPHALUS. PER THE SURGEON, THE CURRENT STATUS OF THE PATIENT WAS FINE AND THEY HAD RETURNED TO BASELINE.
Patient problems: No Code Available
MAUDE report 6514828 ↗InjuryApr 22, 2017Break; Break
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PHYSICIAN STATED THE CATHETER BROKE OFF DURING A PROCEDURE DURING INSERTION. ACCORDING TO THE REPORT, THE CATHETER POPPED OFF/SNAPPED WHILE IN THE PATIENT DURING THE PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED PNEUMOCEPHALUS. PER THE SURGEON, THE CURRENT STATUS OF THE PATIENT WAS FINE AND THEY HAD RETURNED TO BASELINE.
Patient problems: No Code Available
MAUDE report 6514827 ↗InjuryApr 22, 2017Break; Break
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PHYSICIAN STATED THE CATHETER BROKE OFF DURING A PROCEDURE DURING INSERTION. ACCORDING TO THE REPORT, THE CATHETER POPPED OFF/SNAPPED WHILE IN THE PATIENT DURING THE PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED PNEUMOCEPHALUS. PER THE SURGEON, THE CURRENT STATUS OF THE PATIENT WAS FINE AND THEY HAD RETURNED TO BASELINE.
Patient problems: No Code Available
MAUDE report 6514826 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.