NA 27703Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169496880), received between Jul 20, 2017 and May 24, 2021 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING USE, THERE WAS NO ABNORMALITY AT THE INTERFACE OF THE VENTRICULAR DRAINAGE TUBE; HOWEVER, AFTER INSERTING THE INTERFACE, THERE WAS BENDING AT THE INTERFACE, AND IT FRACTURED AND LEAKED CAUSING THE PATIENT'S DRAINAGE PORT GAUZE TO OOZE BLOOD. PRELIMINARY ACTION INDICATED THAT THE HEALTHCARE PROFESSIONAL CUT OFF PART OF THE LEAKING PIPE WALL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11871352 ↗
• MalfunctionNov 30, 2020Disconnection; Disconnection

  IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CONVULSIONS ON (B)(6) 2020. THE PATIENT WAS DIAGNOSED WITH HYDRO CEPHALUS, BRAIN CONTUSION, AND LACERATION. ON (B)(6), THEY WERE SENT TO THE OPERATING ROOM FOR INTRACRANIAL HEMATOMA REMOVAL, DECOMPRESSIVE CRANIECTOMY, VENTRICULAR DRAINAGE, AND INDWELLING VENTRICLE DRAINAGE TUBE. WHEN THE NURSE VISITED THE WARD ON (B)(6), IT WAS FOUND THAT THE FLUID IN THE VENTRICULAR DRAINAGE BAG WAS FULL. WHEN THE DRAINAGE FLUID WAS POURED, THE DRAINAGE BAG WAS FOUND TO BE DISCONNECTED FROM THE JUNCTION OF THE METERING TUBE AND THE DRAINAGE BAG. THE PATIENT WAS DROWSY; HOWEVER, THEIR VITAL SIGNS WERE STABLE. IMMEDIATELY, A STERILE SHEET WAS SPREAD FOR THE PATIENT, THE CONNECTION OF DRAINAGE BAG AND THE TUBE END WERE STERILIZED, AND THIS SITUATION WAS REPORTED TO THE DOCTOR. THE DOCTOR REINFORCED AND CONNECTED THE METERING TUBE AND THE DRAINAGE BAG IN ASEPTIC OPERATION. THE JUNCTION BETWEEN THE METERING TUBE AND THE DRAINAGE BAG WAS REINFORCED WITH SUTURES.

  Patient problems: Fatigue

  MAUDE report 10922824 ↗
• InjuryDec 16, 2019Fluid/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: Fever; Unspecified Infection

  MAUDE report 9476281 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED DURING THE OPERATION, WHEN THE PACKAGE WAS UNPACKED, A HOLE WAS FOUND IN THE CATHETER WALL BETWEEN THE PATIENT'S END 13-14CM. THE CATHETER WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8751002 ↗
• MalfunctionOct 29, 2018Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE EXTERNAL DRAINAGE TUBE WAS PLACED IN THE VENTRICLE PUNCTURE, A CRACK WAS FOUND IN THE CATHETER AT 13CM. THE CATHETER WAS REPLACED AND A NEW ONE WAS USED FOR THE PATIENT FOR EXTRAVENTRICULAR DRAINAGE. 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 8016795 ↗
• MalfunctionMar 1, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CATHETER WAS LEAKING. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS LISTED AS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7308773 ↗
• InjuryNov 15, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER NORMAL PLACEMENT, THE CATHETER BEGAN LEAKING. THE CATHETER WAS EXPLANTED AND REPLACED. THE OUTCOME NOTED NO INJURY TO THE PATIENT. THE PATIENT¿S MEDICAL HISTORY INCLUDED MENINGIOMA INTRAOPERATIVE DRAINAGE.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 7033867 ↗
• MalfunctionJul 20, 2017Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD TRAUMATIC HYDROCEPHALUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6729973 ↗

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