NA 27304Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00673978246055), received between Jun 23, 2017 and Nov 20, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A LUMBAR DRAIN PLACEMENT, THE CATHETER MET RESISTANCE WHILE TRYING TO REPOSITION AND ADVANCE IT. IT BECAME CLEAR THAT THE CATHETER HAD BECOME STUCK AND LIKELY HAD SHEARED. AS SUCH, THE DOCTOR REMOVED THE NEEDLE AND CATHETER AND CONFIRMED THAT APPROXIMATELY 4-5 CM OF THE CATHETER WAS RETAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9347421 ↗
• MalfunctionJul 19, 2018Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS TO HAVE A CONTINUOUS DRAINAGE OF THE LUMBAR CISTERN DUE TO CEREBROSPINAL FLUID LEAKAGE AFTER PITUITARY ADENOMA SURGERY. THE REPORTED DEVICE WAS USED; HOWEVER, LEAKAGE OF THE LUMBAR SPINAL CANAL PREPERFUSION WAS FOUND DURING THE OPERATION. THE SYSTEM WAS REPLACED WITH A NEW ONE TO COMPLETE THE OPERATION. NO ADVERSE CONDITIONS AFTER THE SURGERY. 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 7704910 ↗
• MalfunctionJul 20, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THERE WAS LEAKAGE AT THE THREE-WAY VALVE DURING THE PROCEDURE. ACCORDING TO THE REPORT, THE SYSTEM WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6729974 ↗
• MalfunctionJun 23, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PATIENT PRESENTED TO THE CLINIC WITH GAIT DISTURBANCE. THE PATIENT HAD BEEN DOING WELL UNTIL 2 YEARS AGO WHEN THEIR LEGS JUST GAVE OUT. AT THAT TIME, THEY WERE TAKEN TO THE EMERGENCY DEPARTMENT, BUT NO ETIOLOGY WAS IDENTIFIED. AFTER THAT, THE PATIENT'S GAIT AND MEMORY STARTED TO DECLINE. THEY REPORTED UNSTEADINESS, BUT NO FALLS. ACCORDING TO THE REPORT, THE PATIENT WAS REFERRED FOR EVALUATION OF NPH AND WAS ADMITTED FOR A LUMBAR DRAINAGE AS PART OF THE EVALUATION. NEURORADIOLOGY PLACED A SPINAL NEEDLE AND CATHETER UNDER STERILE CONDITIONS, BUT THE CATHETER WOULD NOT ADVANCE PAST THE NEEDLE TIP. THE CATHETER WAS THEN REMOVED INTACT. REPORTEDLY, AT THE TIME, IT WAS NOTED THAT A 1.5 MM REGION ADJACENT TO THE TIP WAS TORN. THE TEAM OBTAINED IMAGES WHICH DID NOT REVEAL ANY CATHETER REMNANT. OF NOTE, THE CATHETER WAS RADIOPAQUE. THE NEUROLOGIST ASPIRATED CEREBROSPINAL FLUID FROM THE SPINAL NEEDLE AND NO REMNANT WAS FOUND. REPEAT IMAGING AGAIN DID NOT REVEAL ANY REMNANTS IN THE THECAL SAC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6665273 ↗

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-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-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-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
• 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