NA 26040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00673978242323), received between Mar 24, 2017 and Nov 1, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT THE NURSE NOTICED THERE WAS A DETACHED PART ON THE DEVICE. IT WAS STATED THAT IT DID NOT SEEM TO COMPROMISE THE WHOLE SYSTEM, BUT THE PIECE ON THE CHAMBER WAS ABLE TO BE DETACHED IN WHICH IT SHOULD NOT HAVE BEEN ABLE TO DO. IT WAS UNKNOWN WHEN IT WAS DETACHABLE WHETHER IT WAS LIKE THAT IN THE PACKAGING OR HAPPENED AFTER BEING USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9267093 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT THE END PART OF THE EXTENSION LINE THAT WAS CONNECTED TO THE 3 WAY STOPCOCK WAS BROKEN AFTER A SMALL PERIOD OF TIME. THE DOCTOR MENTIONED THAT THE MATERIAL WAS MORE RIGID AND EASILY BREAKABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8917718 ↗
• MalfunctionMay 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORT THAT THE EXTERNAL VENTRICULAR DRAINAGE (EVD) CLAMPS BELOW THE CHAMBER WERE NOT FUNCTIONING AND CEREBROSPINAL FLUID WAS RUNNING INTO THE COLLECTION BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8650656 ↗
• MalfunctionJun 2, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DRAINAGE BAG WAS STUCK PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6609852 ↗
• MalfunctionMar 24, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS INSTALLED BUT WAS NOT DRAINING LIQUID. ACCORDING TO THE REPORT, THE PATIENT DEVELOPED INTRACRANIAL HYPERTENSION. REPORTEDLY, THE DEVICE HAD TO BE REPLACED AND THE PATIENT WAS RECUPERATING.

  Patient problems: No Code Available

  MAUDE report 6434499 ↗

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-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-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-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