N/A 26020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000406035), received between Mar 28, 2024 and Apr 24, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE NEUROSURGERY NURSE INSPECTED THE WARD AND FOUND BLOOD OOZING FROM THE THREE-WAY JOINT OF THE PATIENT'S HEAD DRAINAGE TUBE. THE USAGE OF THE DEVICE WAS STOPPED IMMEDIATELY. THE DOCTOR ON DUTY CHECKED, AND THEN REPLACED THE THREE-WAY JOINT OF THE DRAINAGE TUBE, WHICH DID NOT CAUSE ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900523 ↗
• MalfunctionDec 5, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE OPERATION, WHEN THE EXTERNAL DRAINAGE TUBE WAS INSERTED, THE FRONT END OF THE TUBE WAS FOUND TO BE DAMAGED DURING THE PRE-INFUSION WITH SALINE. THE CATHETER WAS REPLACED WITH A NEW ONE TO COMPLETE THE OPERATION. THERE WAS A PROCEDURE DELAY OF 30 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 20852097 ↗
• InjuryNov 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT AFTER PLACING THE RIGHT VENTRICULAR DRAINAGE TUBE, THE SURGEON DISCOVERED LIQUID LEAKAGE AT THE CATHETER CONNECTOR. THE CATHETER 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 20651585 ↗
• InjuryOct 23, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT IN THE PROCESS OF USING THE CATHETER TO DRAIN, THE DRAINAGE WAS NOT SMOOTH. THE DEVICE WAS REPLACED TO CONTINUE TO DRAIN THE PATIENT. THERE WAS A DELAY IN THE PROCEDURE OF 3 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS CEREBRAL HEMORRHAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513663 ↗
• MalfunctionMar 28, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT DURING THE PATIENT'S CONFUSION AND WHEN THEY GOT UP, THE DRAINAGE TUBE BROKE. AFTER THE DOCTOR REVIEWED THE CT SCAN, THE CONDITION WAS STABLE, AND THE DRAINAGE TUBE WAS PULLED OUT. THERE WAS NO ADVERSE HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992836 ↗