N/A 27703Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000395995), received between May 13, 2022 and Jan 22, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE DOCTOR DISCOVERED FLUID LEAKAGE DURING SURGERY. THERE WAS A PROCEDURE DELAY OF 2 MINUTES. 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 21206989 ↗
• InjurySep 26, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS). IT WAS REPORTED THAT WHEN THE VENTRICULAR CATHETER WAS USED TO CONNECT THE EDMS AT THE 3-WAY POSITION, IT FELL OFF NATURALLY/DETACHED AND COULD NOT BE CONNECTED. THE CATHETER AND EDMS WERE REPLACED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309288 ↗
• MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD A SUBDURAL EFFUSION AND UNDERWENT EXTERNAL DRAINAGE SURGERY. DURING THE SURGERY, THE CATHETER WAS TESTED AND FOUND TO BE LEAKING FOR NO REASON. AFTER REPEATED ATTEMPTS AND CAREFUL OBSERVATION, A PROBLEM WITH THE CATHETER WAS CONFIRMED. THE PRODUCT WAS NOT USED AND WAS REPLACED WITH A NEW ONE. THERE WAS A 20 MINUTE DELAY IN THE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY DUE TO THEIR SUBDURAL EFFUSION, AND IT WAS NOT DUE TO THE REPORTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457704 ↗
• MalfunctionMar 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT THE CATHETER WAS USED FOR POSTOPERATIVE DRAINAGE OF THE PATIENT WITH A CEREBRAL HEMORRHAGE. AFTER 5 DAYS OF USE, IT WAS FOUND THAT THE GAUZE WRAPPED AROUND THE LATERAL VENTRICLE WAS SOAKED. THE GAUZE WAS OPENED, AND LIQUID LEAKAGE WAS FOUND FROM THE TEE OF THE DRAINAGE TUBE. THERE WERE NO OBVIOUS CRACKS. IT WAS IMMEDIATELY DISINFECTED FOR THE PATIENT. THE CATHETER WAS REMOVED. A CT SCAN WAS REVIEWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846152 ↗
• InjuryFeb 1, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT THE UNDERWENT CRANIOTOMY, AND AN EXTERNAL CEREBRAL VENTRICULAR DRAINAGE CATHETER WAS INSTALLED DURING THE SURGERY. AFTER THE SURGERY, IT WAS FOUND THAT THE PATIENT'S EXTERNAL CEREBRAL VENTRICULAR DRAINAGE CATHETER RUPTURED AND LEAKED FLUID, AND CEREBROSPINAL FLUID LEAKED OUT. THE PATIENT DEVELOPED DEEPENING OF CONSCIOUSNESS DISORDER AND FEVER, AND INTRACRANIAL INFECTION WAS CONSIDERED. THE CEREBROSPINAL FLUID CULTURE WAS PERFORMED AND SHOWED THE GROWTH OF STAPHYLOCOCCUS EPIDERMIDIS AND STAPHYLOCOCCUS HOMINIS, WHICH CONFIRMED INTRACRANIAL INFECTION, AND ANTI-INFECTIVE TREATMENT WAS GIVEN. THE PATIENT'S FEVER IMPROVED, BUT THEIR CONSCIOUSNESS WAS POOR, AND THE FAMILY FINALLY GAVE UP TREATMENT AND THE PATIENT WAS DISCHARGED.

  Patient problems: Bacterial Infection; Fever; Loss of consciousness

  MAUDE report 18624555 ↗
• MalfunctionJan 5, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT DURING AN EMERGENCY SURGERY, A HOLE WAS FOUND IN THE SIDE WALL OF THE CATHETER LOCATED AT APPROXIMATELY THE 6.5 CM MARK CAUSING LEAKAGE PRIOR TO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455465 ↗
• MalfunctionDec 12, 2023Component Missing; Component Missing

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED AFTER OPENING THE PRODUCT, THE MEDICAL STAFF FOUND THAT THE CATHETER WAS MISSING THE LUER CONNECTOR. THE CATHETER WAS REPLACED TO PROCEED WITH A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311610 ↗
• MalfunctionNov 27, 2023Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT DURING THE PATENCY TEST BEFORE IMPLANTING THE PRODUCT, IT WAS FOUND THAT THE DRAINAGE WAS NOT SMOOTH. THE CATHETER WAS REPLACED WITH A NEW ONE IMMEDIATELY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211349 ↗
• InjuryOct 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING POST-OPERATIVE CARE, LEAKAGE WAS FOUND AT THE TEE POSITION. IN ORDER TO AVOID FURTHER INFECTION, ALL CONSUMABLES WERE REMOVED AND REPLACED WITH NEW CONSUMABLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038324 ↗
• MalfunctionMay 8, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE TUBE WAS BLOCKED RESULTING IN POOR DRAINAGE. A DIFFERENT DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887371 ↗
• MalfunctionDec 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING A DRAINAGE DEVICE. IT WAS REPORTED THAT THE PRODUCT CONNECTOR WAS FIXED UNSTABLY. THIS ISSUE WAS FOUND DURING USE, AND IT WAS REPLACED WITH A NEW ONE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932351 ↗
• MalfunctionMay 18, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING CATHETERS USED DURING A PROCEDURE. IT WAS REPORTED THAT IT WAS FOUND THAT TWO DRAINAGE TUBES WERE BROKEN, WHICH WERE LOCATED AT 6 CM AND 7 CM, RESPECTIVELY. THE PRODUCTS WERE NOT USED. THERE WAS SUSPECTED TO BE A PRODUCT QUALITY PROBLEM. NEITHER DELAY NOR PATIENT IMPACT INFORMATION WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431222 ↗
• MalfunctionMay 18, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING CATHETERS USED DURING A PROCEDURE. IT WAS REPORTED THAT IT WAS FOUND THAT TWO DRAINAGE TUBES WERE BROKEN, WHICH WERE LOCATED AT 6 CM AND 7 CM, RESPECTIVELY. THE PRODUCTS WERE NOT USED. THERE WAS SUSPECTED TO BE A PRODUCT QUALITY PROBLEM. NEITHER DELAY NOR PATIENT IMPACT INFORMATION WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431208 ↗
• MalfunctionMay 13, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE OPERATION, IT WAS FOUND THAT THE PLASTIC PIPE OF THE DRAINAGE TUBE WAS DEFORMED AND DID NOT MATCH THE METAL CONE, SO IT WAS NOT USED AND WAS RETURNED. IT WAS REPORTED THAT NO PATIENT WAS INVOLVED, WHICH CONTRADICTS OTHER REPORTED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402556 ↗
• MalfunctionMay 13, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE OPERATION, IT WAS FOUND THAT THE PLASTIC PIPE OF THE DRAINAGE TUBE WAS DEFORMED AND DID NOT MATCH THE METAL CONE, SO IT WAS NOT USED AND WAS RETURNED. IT WAS REPORTED THAT NO PATIENT WAS INVOLVED, WHICH CONTRADICTS OTHER REPORTED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402555 ↗

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-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-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-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
• 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-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