N/A 27304 (UDI 00763000406097)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000406097), received between May 19, 2022 and May 20, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2026, THE DOCTOR PERFORMED A LUMBAR PUNCTURE AND CATHETER PLACEMENT UNDER LOCAL ANESTHESIA, AND A LUMBAR CISTERN DRAINAGE TUBE WAS INSERTED. THE PROCEDURE WAS SMOOTH AND THE TUBE WAS PROPERLY SECURED. ON (B)(6) 2026, A SMALL AMOUNT OF DRAINAGE FLUID LEAKAGE WAS OBSERVED AT THE THREE-WAY CONNECTOR. UPON CAREFUL INSPECTION, A CRACK WAS FOUND IN THE THREE-WAY CONNECTOR OF THE DRAINAGE TUBE. THE DRAINAGE TUBE WAS IMMEDIATELY REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232232 ↗
• MalfunctionNov 13, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PRODUCT WAS USED FOR LUMBAR PUNCTURE CATHETERIZATION. THE CONNECTION SITE RUPTURED AND WAS BROKEN. THEREFORE, A 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 23542932 ↗
• MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT WAS ADMITTED FOR INTRACRANIAL INFECTION AFTER A BRAIN TRAUMA AND REQUIRED A LUMBAR EXTERNAL DRAINAGE. THE DEVICE WAS USED, AND LEAKAGE WAS FOUND IN THE INTERFACE DURING THE OPERATION. THE DEVICE WAS REPLACED WITH A BRAND NEW ONE. 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 22327000 ↗
• MalfunctionMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT REQUIRED LUMBAR EXTERNAL DRAINAGE DUE TO SUBARACHNOID HEMORRHAGE. DURING THE SURGERY, IT WAS FOUND THAT THE DRAINAGE TUBE WAS LEAKING, AND IT WAS SUBSEQUENTLY 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 21618257 ↗
• InjuryFeb 28, 2024Break; Complete Blockage; Fracture; Break; Complete Blockage; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. DURING THE IMPLANTATION PROCESS INTO THE PATIENT ON (B)(4) 2024, NO FLUID WAS FOUND TO FLOW OUT AFTER THE CATHETER WAS IMPLANTED. AFTER REPEATED OBSERVATIONS AND SEARCHES, IT WAS FOUND THAT THERE WAS A SMALL HOLE IN THE CATHETER THAT PREVENTED DRAINAGE. BECAUSE IT WAS TRIED TO CUT THE SMALL HOLE AND THEN CONNECT THE DRAINAGE BAG, THE REMEDY COULD NOT BE COMPLETED. THEREFORE, REPLACED IT WITH A NEW LUMBAR ABDOMINAL DRAINAGE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796580 ↗
• MalfunctionJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE PATIENT REQUIRED EXTERNAL DRAINAGE OF LUMBAR CISTERNA DUE TO A SUBARACHNOID HEMORRHAGE. DURING SURGERY, THE DRAINAGE TUBE LEAKED LIQUID, A NEW ONE WAS USED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080849 ↗
• MalfunctionApr 13, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED ON (B)(6) 2023 AT 13:20 THE PATIENT RECEIVED AN EMDS. AT 16:30 ON (B)(6) 2023 THE PATIENT DEFECATED AND TURNED OVER TO WIPE. WITHOUT ANY RESISTANCE, THE HOSE JOINT OF THE LUMBAR CISTERN DRAINAGE TUBE FELL OFF. IMMEDIATELY REPORTED TO THE DOCTOR AND THE DOCTOR REMOVED THE DRAINAGE TUBE AND APPLIED A STERILE DRESSING FOR PROTECTION AFTER DISINFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733691 ↗
• MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE SYSTEM BEING USED IN A LUMBAR CISTERN DRAINAGE DUE TO AN INTRACRANIAL INFECTION AFTER A BRAIN TUMOR SURGERY. DURING INTRAOPERATIVE DRAINAGE, A LEAK WAS FOUND. THEY REPLACED WITH A NEW PRODUCT TO CONTINUE SURGERY. THERE WAS A REPORTED DELAY OF 10 MINUTES, AND NO REPORTED IMPACT TO PATIENT OUTCOME. THE LEAK OCCURRED ABOVE DRAINAGE BAG. THE INFECTION OCCURRED ABOUT SEVEN DAYS AFTER TUMOR SURGERY, WHICH HAD NOTHING TO DO WITH MEDTRONIC PRODUCT. IT WAS REPORTED THAT THERE WERE MANY FACTORS OF POSTOPERATIVE INFECTION, AND THE DOCTOR HAD NOT IDENTIFIED THE SPECIFIC CAUSE, BUT THE INFECTION OCCURRED BEFORE THE USE OF OUR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438009 ↗