NA 27303Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00673978246048), received between Nov 16, 2016 and Jul 20, 2021 — classified as 9 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

6 other recalls cover devices cleared under the same FDA submission (K984053); they may or may not involve this specific model.

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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Break; Fluid/Blood Leak; Infusion or Flow Problem; Break; Fluid/Blood Leak; Infusion or Flow Problem

  IT WAS REPORTED THAT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021 DUE TO HYDROCEPHALUS. THE LUMBAR CISTERN DRAINAGE SURGERY WAS PERFORMED, AND THE PUNCTURE PROCESS WAS SMOOTH AS WELL AS THE DRAINAGE. AFTER THE DRAINAGE TUBE WAS PLACED, THE DRAINAGE WAS NOT SMOOTH. AFTER ADJUSTING THE POSITION, THE DRAINAGE WAS STILL NOT SMOOTH. IT WAS STATED IT WAS PROPERLY FIXED AFTER APPLICATION AND DID NOT COME OUT. LATER THAT DAY ON (B)(6) 2021, IT WAS FOUND THAT THERE WAS LITTLE DRAINAGE FLUID IN THE DRAINAGE BAG, AND THE DRAINAGE TUBE WAS NOT FOUND TO BE PROLAPSED, KINKED, OR BENT AFTER THE DOCTOR CHECKED IT. AFTER REPLACING THE DRAINAGE BAG OF THE EXTRACRANIAL DRAINAGE DEVICE, THE DRAINAGE FLUID COULD BE DRAINED AT A RAT OF 1ML PER MINUTE. ON (B)(6) 2021, WHEN THE PATIENT WAS LYING ON THEIR SIDE, IT WAS FOUND THAT THE DRESSING AT THE LUMBAR CISTERN PUNCTURE SITE WAS LEAKING. THE DOCTOR WAS IMMEDIATELY INFORMED AND OPENED THE DRESSING. IT WAS FOUND THAT THE DRAINAGE TUBE OF THE LUMBAR CISTERN WAS PROLAPSED, AND THE DRESSING WAS CHANGED IN TIME. IT WAS NOTED THAT THE DRAINAGE TUBE OF THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM'S LUMEN WAS THIN AND TOO SOFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197436 ↗
• InjuryMar 2, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S ALIVE WITH-INJURY STATUS WAS CLARIFIED AS THAT A CRANIOTOMY WAS PERFORMED ON THE PATIENT, BUT THEY HAD NOT YET WOKEN UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402025 ↗
• InjuryFeb 22, 2021Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS ONLY ONE RED HEPARIN CAP IN THE LUMBAR CISTERN, AND THE RED HEPARIN CAP WAS BROKEN.

  Patient problems: Cognitive Changes; Unspecified Infection

  MAUDE report 11362016 ↗
• InjurySep 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT'S CURRENT STATUS WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10509970 ↗
• MalfunctionJul 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10321096 ↗
• InjuryJul 6, 2020Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE CRACKED BAG WAS UNKNOWN. IT WAS FOUND SUDDENLY CRACKED DURING USE. AT PRESENT, THERE WERE NO EXTERNAL FACTORS CAUSING THE CRACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10236589 ↗
• MalfunctionMay 18, 2020Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SURGERY DOCTOR DIAGNOSED THE PATIENT AS CLOSED CRANIOCEREBRAL INJURY. AFTER CONVEN TIONAL PUNCTURE, IT WAS FOUND NOT EASY TO PLACE THE TUBE AND FELT STUCK WHEN WITHDRAWN. AFTER THE TUBE WAS REMOVED, IT COULD BE OBSERVED DEFORMATION AND EXTRUSION AT DRAINAGE TUBE SIDE HOLE. THE DOCTOR HAD REPLACED IT WITH A NEW TUBE ON THE SAME DAY, AND THE IMPLA NTATION WENT SMOOTHLY. THE ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WAS STATED AS FOLLOWS: SINCE THE PUNCTURE NEEDLE IN THE LUMBAR CISTERN WAS SLIGHTLY COCKED, WHICH WAS DESIGNED TO FACILITATE THE CLINICIAN TO MOVE THE TUBE TO THE LUMBAR LACUNAE DURING THE IMPLANTATION PROCESS, IT WAS EASY TO CAUSE THE TUBE TO BE STUCK ON THE NEEDLE WHEN WITHDRAWING THE TUBE, RESULTING IN DEFORMATION AND EXTRUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10068111 ↗
• InjuryMay 18, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ACCORDING TO THE CLINICAL DOCTOR, AFTER THE LUMBAR DRAINAGE SURGERY WAS PERFORMED ON THE PATIENT, THE INTRAOPERATIVE CATHETER WAS SUCCESSFULLY PLACED, AND THE CLAMP WAS FIXED WELL. THEN, IT WAS FOUND CEREBROSPINAL FLUID LEAKAGE AT THE POSITION OF ABOUT 10 CM AT THE POSTERIOR SIDE, AND THE CATHETER WAS IMMEDIATELY REPLACED. IT WAS NOTED THAT THE RUPTURED DRAINAGE CATHETER WAS AN EXTERNAL DRAINAGE CATHETER OF THE LUMBAR SPINE, THE DEVICE'S IMPLANTABLE THIN TUBE. AFTER THAT, THE PATIENT HAD NO ADVERSE REACTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10068091 ↗
• MalfunctionMay 12, 2020Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO BROKEN PIECE LEFT IN THE PATIENT, AND NO PATIENT COMPLICATION WAS REPORTED AS THE RESULT OF THEEVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10049791 ↗
• InjuryMay 1, 2020Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10017790 ↗
• MalfunctionMar 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE LUMBAR EXTERNAL DRAINAGE CATHETER, IT WAS FOUND THAT THERE WAS WATER LEAKAGE AT ABOUT 40CM. THE CATHETER WAS REPLACED WITH A NEW ONE TO CONTINUE THE SURGERY. THERE WAS NOT ANY PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9891928 ↗
• MalfunctionFeb 12, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE NURSE PREPARED TO RELEASE THE DRAINAGE FLUID FOR THE PATIENT AND FOUND THAT THE EXIT OF THE LUMBAR SPINAL DRAINAGE MONITORING SYSTEM WAS SEALED AND COULD NOT LET THE DRAINAGE FLUID OUT. THE DRAINAGE BAG WAS REPLACED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9703569 ↗
• InjuryFeb 10, 2020Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9690086 ↗
• MalfunctionJan 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHEN THE DOCTOR WAS DRAINING THE LUMBAR CISTERN, THE LUMBAR CATHETER COULD NOT BE SENT INTO THE SPINAL CANAL NORMALLY. THE DOCTOR SUSPECTED WHETHER THE NEEDLE WAS TOO THIN AND/OR THE LUMBAR CATHETER WAS TOO SOFT. THE DEVICE WAS REPLACED WITH THE PRODUCT OF THE SAME MODEL TO COMPLETE THE SURGERY. THE EVENT RESULTED IN A 30 MINUTE DELAY IN PROCEDURE. THE PATIENT'S MEDICAL HISTORY WAS TRAUMATIC BRAIN INJURY. THEIR STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9623584 ↗
• MalfunctionJan 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A CEREBRAL HEMORRHAGE, AND WHEN THE DOCTOR PERFORMED THE EXTERNAL DRAINAGE OF THE LUMBAR CISTERNA, THE CEREBROSPINAL FLUID COULD NOT BE NORMALLY DRAINED AFTER THE EXTERNAL DRAINAGE BAG WAS CONNECTED. IT WAS NOTED THAT THE DOCTOR ALSO FELT THAT TI COULD BE THAT THE LUMBAR CATHETER WAS TOO THIN OR THAT THERE WERE TOO FEW LATERAL HOLES IN THE LUMBAR CATHETER WHICH WERE TOO SMALL. THE DEVICE WAS REPLACED WITH ONE OF THE SAME MODEL, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REPORTED EVENT RESULTED IN A 30 MINUTE DELAY IN PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9622408 ↗
• MalfunctionJan 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD A CEREBROSPINAL FLUID LEAK AFTER PITUITARY TUMOR SURGERY; THEREFORE, THE PATIENT WAS IMPLANTED WITH A LUMBAR DRAIN ON (B)(6) 2020. DURING THE SURGERY, A FRACTURE OCCURRED DURING THE PUNCTURE AND PLACEMENT OF THE TUBE. THE DEVICE WAS REPLACED, AND THE SURGERY WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575297 ↗
• MalfunctionJul 22, 2019Fracture; Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT NASAL NERVE ENDOSCOPIC SADDLE AREA TUMOR RESECTION SURGERY AND HAD POSTOPERATIVE CEREBROSPINAL FLUID RHINORRHEA. THE LUMBAR CISTERN DRAINAGE TUBE 15 CM WAS PLACED AND FIXED IN THE LOWER BACK. ON (B)(6) 2019, DURING THE EXTUBATION, THE LUMBAR DRAINAGE TUBE BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8812330 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE USAGE OF THE DRAINAGE DEVICE, LEAKAGE WAS FOUND. 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 Known Impact Or Consequence To Patient

  MAUDE report 8750458 ↗
• MalfunctionApr 16, 2019Fracture; Fracture

  IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A LUMBOSACRAL DRAINAGE DEVICE ON (B)(6) 2019, AND DURING THE OPERATION, THE CATHETER BROKE AFTER OPENING THE PACKAGE. THE HOSPITAL UNPACKED A STOCK PRODUCT FOR REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8518402 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD RECOVERED AND BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Hematoma

  MAUDE report 8404255 ↗
• MalfunctionMar 6, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE OPERATION, THE PHYSICIAN FOUND THAT CEREBROSPINAL FLUID DID NOT FLOW OUT OF THE CATHETER AND THAT THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER WAS IMPASSABLE AFTER LUMBAR PUNCTURE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT. AFTER THE EVENT, THE PHYSICIAN CHANGED THE DEVICE WITH THE SAME MODEL IN TIME, WHICH DID NOT HAVE A GREAT IMPACT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8395335 ↗
• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO THE EVENT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8358255 ↗
• MalfunctionJan 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DRAINAGE SYSTEM LEAKED. THE PRODUCT WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227884 ↗
• MalfunctionSep 13, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS TO UNDERGO LUMBAR DRAINAGE DUE TO INTRACRANIAL HEMORRHAGIC OCCUPYING INFLAMMATORY LESIONS. WHEN THE PACKAGE WAS OPENED DURING THE OPERATION, IT WAS FOUND THAT THE CATHETER WAS DISTORTED. THE CATHETER WAS NOT USED AND WAS REPLACED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7873013 ↗
• MalfunctionMay 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PHYSICIAN WAS GOING TO USE THE EXTERNAL DRAINAGE FOR AN INTRACRANIAL INFECTION; HOWEVER, IT WAS FOUND THAT THE CATHETER WAS LEAKING DURING THE PRE-OPERATIVE TEST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554781 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K984053. One submission often covers many models, so check the product and lot details in each record.

• Z-2412-2023 · Jun 28, 2023 · Open, Classified
  Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
• Z-1922-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrosp
• Z-1921-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and o
• Z-1920-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and o
• Z-1923-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrosp
• Z-1924-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal