N/A 27304 (UDI 00763000343217)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000343217), received between Jun 14, 2021 and May 20, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT LUMBAR EXTERNAL DRAINAGE DUE TO INTRACRANIAL INFECTION FOLLOWING A TRAUMATIC BRAIN INJURY. POSTOPERATIVELY, FLUID LEAKAGE WAS NOTED IN THE DRAINAGE TUBE, AND A BRAND NEW DEVICE WAS USED INSTEAD. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230111 ↗
• MalfunctionJan 15, 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 INTRACRANIAL INFECTION AFTER BRAIN TRAUMA. THE REPORTED DEVICE WAS USED. AFTER THE SURGERY, THE DRAINAGE TUBE WAS FOUND TO BE LEAKING. 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 21157771 ↗
• InjuryFeb 1, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. ON (B)(6) 2024, THE DOCTOR USED THE EXTERNAL LUMBAR DRAINAGE AND MONITORING SYSTEM TO PERFORM LUMBAR PUNCTURE AND CATHETERIZATION SURGERY ON THE PATIENT. AFTER THE SURGERY, AN EXTERNAL LUMBAR DRAINAGE CATHETER WAS PLACED FOR DRAINAGE. ON (B)(6) 2024, THE NURSE DISCOVERED THAT THE HOSE OF THE LUMBAR PUNCTURE KIT HAD A CRACK AND CEREBROSPINAL FLUID WAS FLOWING OUT. THE NURSE PROMPTLY NOTIFIED THE DOCTOR ON DUTY TO DEAL WITH IT, AND THE DOCTOR PROMPTLY REMOVED IT AND CHANGED THE DRESSING. NO SERIOUS HARM WAS FOUND TO THE PATIENT YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623174 ↗
• InjuryNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE PATIENT WAS ADMITTED TO OUR HOSPITAL DUE TO BRAIN TUMOR AND SUBARACHNOID HEMORRHAGE. ACCORDING TO THE PATIENT'S CONDITION, LUMBAR PUNCTURE AND DRAINAGE WAS PERFORMED UNDER LOCAL ANESTHESIA USING EXTERNAL LUMBAR DRAINAGE AND MONITORING SYSTEM ON (B)(6) 2023. AFTER THE PUNCTURE WAS COMPLETED, WHEN THE DRAINAGE BAG WAS CONNECTED, LEAKAGE WAS FOUND IN THE DRAINAGE TUBE. THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM WAS IMMEDIATELY REPLACED AND THE PATIENT WAS RE-PUNCTURED. AFTER THE PUNCTURE WAS COMPLETED, THE DRAINAGE WAS SMOOTH AND THE OPERATION WAS SUCCESSFULLY COMPLETED. DUE TO TIMELY DISCOVERY, NO ADVERSE EFFECTS WERE CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237652 ↗
• MalfunctionApr 4, 2022Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING A DRAINAGE DEVICE USED DURING A PROCEDURE. IT WAS REPORTED THAT DURING THE EXTERNAL LUMBAR DRAINAGE OPERATION, THE DOCTOR FOUND THAT THE JUNCTION BETWEEN THE LUMBAR SPINAL CANAL AND THE DRAINAGE BAG FELL OFF DURING THE PROCESS OF IMPLANTING THE MATERIAL. THE PRODUCT WAS DAMAGED. THE OPERATION WENT SMOOTHLY AFTER REPLACING WITH OTHER SIMILAR PRODUCTS. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DAMAGE WAS LOCATED IN THE DRAINAGE BAG WHERE THE PROXIMAL END OF THE PATIENT CONNECTION CATHETER AND THE LUMBAR CATHETER WERE CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996564 ↗
• MalfunctionNov 16, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THE PATIENT UNDERWENT LUMBAR CISTERN DRAINAGE ON (B)(6) 2021, AND THE REPORTED EXTERNAL LUMBAR DRAINAGE COLLECTION MONITORING SYSTEM WAS USED. THE ORIGINAL EXPOSED PART OUT OF THE BODY HAD A THREE-POINT MARK (THE MARK LENGTH WAS 20CM), BUT ONLY TWO POINTS WERE LEFT (THE MARK LENGTH WAS 15CM); AND THE FOUR-POINT MARK (THE MARK LENGTH WAS 25CM) WAS ALSO FADED AND UNRECOGNIZABLE . AS A RESULT, THE DEPTH OF THE LUMBAR CISTERN TUBE COULDN'T BE IDENTIFIED. COMBINED WITH THE DRAINAGE SITUATION, AND CONSIDERED THAT THE CONTINUED INDWELLING MAY INCREASE THE RISK OF INTRACRANIAL INFECTION, IT WAS REMOVED. AFTER REMOVAL, IT WAS FOUND THAT THE DRAINAGE TUBE DID NOT COME OFF, BUT IT WAS FADED AS DESCRIBED. CONSIDERING THAT THE MARKING METHOD WAS NOT RELIABLE ENOUGH, THE OPERATIONS OF DISINFECTION, RUBBING, AND STICKING OF AUXILIARY MATERIALS COULD CAUSE THE COLOR TO FADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824371 ↗
• InjuryOct 1, 2021Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S CURRENT STATUS WAS THAT THEY HAD BEEN DISCHARGED.

  Patient problems: Fever; Vomiting

  MAUDE report 12563086 ↗
• MalfunctionJun 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT AFTER THE EXTERNAL DRAINAGE WAS FINISHED BEING USED ON THE PATIENT, THE DOCTOR REMOVED THE CATHETER FROM THE LUMBAR SPINE; HOWEVER, DURING THE REMOVAL, THE END OF THE TIP BROKE AND WAS MISSING INSIDE THE CEREBROSPINAL FLUID IN THE LUMBAR SPINE REGION AND NOT RETRIEVED. THE DOCTOR FELT THAT THE THERE WAS A DIFFERENCE IN THE PRODUCT COMPARED TO PREVIOUS PRODUCT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11995845 ↗