N/A 44010Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00763000030292), received between Apr 12, 2021 and Aug 14, 2026 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Break; Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252435 ↗
• MalfunctionAug 10, 2026Break; Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192219 ↗
• MalfunctionMay 20, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT REQUIRED IMPLANTATION OF A RESERVOIR DUE TO INTRACEREBRAL HEMORRHAGE. DURING THE PROCEDURE, FLUID LEAKAGE FROM THE DRAINAGE TUBE WAS OBSERVED, AND IT WAS SUBSEQUENTLY REPLACED WITH A NEW DEVICE. THERE WAS A PROCEDURE DELAY OF 10 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230271 ↗
• MalfunctionDec 24, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT DURING THE SURGERY, UPON OPENING THE OUTER PACKAGING, IT WAS DISCOVERED THAT THERE WERE BROKEN/FRACTURED PARTS INSIDE THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887560 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT THERE WAS RESERVOIR LIQUID LEAKAGE. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568555 ↗
• MalfunctionSep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT WHEN OPENING THE DEVICE AND FILLING WATER ON THE OPERATING TABLE, A LEAK WAS DISCOVERED. IN ORDER TO ENSURE THE SMOOTH PROGRESS OF THE OPERATION, A NEW ONE WAS OPENED TO CONTINUE THE OPERATION. THE OPERATION WENT SMOOTHLY, AND THE FOLLOW UP WAS GOOD. THE PATIENT'S MEDICAL HISTORY WAS LUNG CANCER BRAIN METASTASIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037139 ↗
• MalfunctionSep 2, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A PORT. IT WAS REPORTED THAT DURING THE OPERATION, THE DRAINAGE TUBE BROKE. THE SURGERY WAS COMPLETED AFTER THE DEVICE WAS REPLACED. THERE WAS A PROCEDURE DELAY OF 10 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY. THE INJURY WAS CLARIFIED AS THE FOLLOWING: THE DRAINAGE TUBE RUPTURED, CAUSING THE FLUID IN THE TUBE TO LEAK OUT, REQUIRING RE-CLEANING, AND PROLONGING THE OPERATION TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939329 ↗
• MalfunctionFeb 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT THE DEVICE HAD A PROBLEM OF WATER LEAKAGE IN THE LIQUID STORAGE PUMP. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469431 ↗
• MalfunctionFeb 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT DURING THE OPERATION, THE PRODUCT WAS TESTED AND LIQUID LEAKAGE OF THE RESERVOIR BAG WAS FOUND. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THERE WAS A PROCEDURE DELAY OF 2 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432136 ↗
• MalfunctionFeb 21, 2025Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT THE DOCTOR TESTED THE PRODUCT DURING THE OPERATION AND FOUND THAT THE RESERVOIR BAG WAS BLOCKED AND NO FLUID WAS DRIPPING. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THERE WAS A PROCEDURE DELAY OF 2 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432043 ↗
• MalfunctionFeb 18, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT THE OMMAYA SAC WAS IMPLANTED INTO THE CEREBRAL VENTRICLE, AND A FISSURE APPEARED IN THE FLUID RESERVOIR ALLOWING CEREBROSPINAL FLUID TO FLOW OUT. THE DEVICE WAS REPLACED. THERE WAS A PROCEDURE DELAY OF 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404918 ↗
• MalfunctionFeb 10, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT ON (B)(6) 2024, THE DOCTOR DISCOVERED THAT THE WHITE CATHETER WAS BROKEN BEFORE THE SURGERY. THERE WAS A PROCEDURE DELAY OF 1 MINUTE. THE PROCEDURE WAS COMPLETE WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343324 ↗
• MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT ON (B)(6) 2025, DURING THE OPERATION, WHEN USING THE FLUSHING CEREBROSPINAL FLUID SHUNT TUBE ACCESSORIES, LEAKAGE WAS FOUND IN THE VENTRICULAR END RESERVOIR. THE DEVICE WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A PROLONGED SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208223 ↗
• MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT WHEN THE DOCTOR CHECKED THE PRODUCT DURING THE OPERATION, IT WAS FOUND THAT THE RESERVOIR WAS LEAKING. THERE WAS A PROCEDURE DELAY OF 1 MINUTE. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207080 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT ON (B)(6) 2024, THE NEUROSURGEON DISCOVERED THAT THE DEVICE WAS LEAKING WHILE PERFORMING AN OMMAYA CAPSULE IMPLANT ON THE PATIENT. THE DEVICE WAS REPLACED WITH BACK UP PRODUCT OF THE SAME MODEL WHICH MADE THE OPERATION GO SMOOTHLY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123176 ↗
• MalfunctionJan 23, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT WHEN THE DOCTOR WAS PERFORMING CHEMOTHERAPY PORT PLACEMENT ON THE PATIENT, THE PACKAGE WAS OPENED, AND IT WAS FOUND THERE WAS A CRACK AT THE CONNECTION BETWEEN THE RESERVOIR AND THE VENTRICULAR END TUBE. THE DEVICE WAS REPLACED FOR A NEW ONE TO COMPLETE THE SURGERY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562504 ↗
• MalfunctionNov 16, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A PORT. IT WAS REPORTED THAT THE TAIL END OF THE BRAIN VENTRICLE END CATHETER WAS BROKEN. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148811 ↗
• MalfunctionSep 14, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS REPORTED THAT ON (B)(6), 2023, THE DOCTOR DISCOVERED DURING THE OPERATION THAT THE RESERVOIR BAG WAS RUPTURED AND LEAKING FLUID. THE DEVICE WAS REPLACED WITH THE PRODUCT OF THE SAME MODEL. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744004 ↗
• MalfunctionMay 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. IT WAS TESTED DURING THE OPERATION AND FOUND TO BE LEAKING FROM THE RESERVOIR. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020524 ↗
• InjuryMay 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT DURING THE SURGICAL IMPLANTATION OF THE RESERVOIR, A LEAKAGE OF LIQUID WAS FOUND AND THE DEVICE WAS REPLACED. IT WAS FOUND IN THE INSPECTION PROCESS AFTER IMPLANTING, REPLACED WITH OUR BACKUP PRODUCT IMMEDIATELY FOR SURGERY. THE REPRESENTATIVE REPORTED THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16888028 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE FRONT END OF THE TUBE WAS DAMAGED, AND RESULTED IN LIQUID LEAKAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742956 ↗
• InjuryMar 27, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A PORT. IT WAS REPORTED ON (B)(6) 2022, THE PATIENT HAD BILATERAL SUBDURAL EFFUSION. ON (B)(6) 2022, THE LEFT OMMAYA SAC WAS IMPLANTED WITH SUBDURAL EFFUSION/BLOOD DRILLING AND DRAINAGE. DURING THE OPERATION, THE RESISTANCE OF THE OMMAYA SAC WAS VERY HIGH, AND THE CEREBROSPINAL FLUID COULD NOT BE EXTRACTED DURING THE TEST. THE DOCTOR TOOK OUT THE SAC DURING THE OPERATION, AND THE TEST WITH SALINE WAS ALSO VERY RESISTANT, THE SAME SITUATION. AFTER COMMUNICATION, THE FIRST DEVICE WAS REPLACED WITH A SET OF 44010 TO USE, OTHERWISE THE OPERATION COULD NOT BE CARRIED. THERE WAS A 40 MINUTE DELAY. THE SURGERY WAS COMPLETED WITH A DIFFERENT PRODUCT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16622199 ↗
• MalfunctionFeb 23, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING SURGERY THE CATHETER WAS BROKEN. IT WAS NOTED THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428034 ↗
• MalfunctionNov 29, 2022Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A PORT DEVICE, IT WAS REPORTED THAT THE PRODUCT WAS TESTED DURING THE OPERATION, AND WAS FOUND THAT THE FLUID RESERVOIR COULD NOT PUMP LIQUID, AND THE PRODUCT WAS REQUIRED TO BE REPLACED. THERE WAS A REPORTED DELAY OF 1 MINUTE. THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15879746 ↗
• MalfunctionMay 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A VENTRICULAR PORT. AFTER IMPLANTING THIS LIQUID STORAGE BAG INTO THE PATIENT, THE TUBE LEAKED LIQUID. THE DOCTOR ASKED THE PATIENT TO REPLACE THE LIQUID STORAGE BAG. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498144 ↗