NA 27302 (UDI 00673978246031)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00673978246031), received between Mar 16, 2017 and May 10, 2018 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2018Break; Break

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DOCTOR RECOGNIZED THAT THE CATHETER HAD A TEAR IN IT. THE CATHETER WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503227 ↗
• MalfunctionFeb 6, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE THE ¿GUIDE¿ WAS BEING REMOVED DURING THE PROCEDURE, IT CREATED HOLES INSIDE THE CATHETER, LEADING TO THE LEAKING OF CEREBROSPINAL FLUID. IT WAS INDICATED THERE WERE NO SYMPTOMS ASSOCIATED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7244206 ↗
• DeathNov 22, 2017Break; Device Or Device Fragments Location Unknown; Break; Device Or Device Fragments Location Unknown

  IT WAS REPORTED AN ANESTHESIOLOGIST STATED THAT THE DEVICE BROKE OFF INTO THE PATIENT. IT WAS STATED THAT THE DEVICE WAS REMOVED ON (B)(6) 2017, AND WHILE WITHDRAWING THE CATHETER SLOWLY AND DELIBERATELY, THE CATHETER SNAPPED OFF PRIOR TO EXITING THE SPINAL COLUMN. IT WAS NOTED THAT WHEN THE CATHETER FRACTURED, A 12 CM SEGMENT LEFT REMAINING IN THE PATIENT. THE PATIENT UNDERWENT REMOVAL OF THE REMAINDER OF THE CATHETER LATER. IT WAS STATED THAT THE PATIENT DIED ON (B)(6) 2017.

  Patient problems: Death; Device Embedded In Tissue or Plaque

  MAUDE report 7054719 ↗
• MalfunctionApr 7, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE TIP OF THE CATHETER OR TUOHY NEEDLE WAS BROKEN DURING THE PROCEDURE. ACCORDING TO THE REPORT, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6471573 ↗
• MalfunctionMar 16, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT UPON INSERTION OF THE CATHETER, IT WAS DECIDED TO PULL THE CATHETER OUT AS IT WAS NOT IN A GOOD SPACE WITHOUT THE TUOHY NEEDLE IN POSITION. ACCORDING TO THE REPORT, THE CATHETER SNAPPED OFF AND WAS LEFT IN THE PATIENT. REPORTEDLY, THE PHYSICIAN DECIDED TO LEAVE IT THERE AND INDICATED IT WOULD BE FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6411434 ↗

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-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
• 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