Duet® 46914 (UDI 00613994445377)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00613994445377), received between Mar 22, 2017 and Aug 14, 2023 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 22, 2024Open, Classified

   Potential for catheter disconnection from the patient line stopcock connectors.

   Z-1163-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2023Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE STOPCOCK WAS LOOSE. THE ISSUE WAS NOTED TO BE AN OUT OF BOX FAILURE. THE ISSUE OCCURRED WITH A PATIENT WITHIN 5 MINUTES OF USE, AND WAS DISCOVERED AFTER SET UP ON ZEROING. THERE WAS NO REPORTED IMPACT TO PATIENT OR MEDICAL INTERVENTION. THE SITE REPORTED THAT THE STOPCOCK WAS ATTACHED TO THE FLANGE USED TO INSERT INTO THE DRAINING SYSTEM AT THE VENTRICULAR LEVEL WAS LOSE AND KEPT FALLING OUT OF THE HOUSING. A SECOND DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17543944 ↗
• InjuryApr 25, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS) USED DURING A PROCEDURE. IT WAS REPORTED THAT THE EXTERNAL VENTRICULAR DRAINAGE IN ICU, SYSTEMS CONTINUE TO FAIL AT THE PROXIMAL PORT CLOSEST TO THE PATIENT. THE PRODUCT WAS DAMAGED. THE SITE WAS NOT SURE WHICH OF THE 2 LOT NUMBERS IN CIRCULATION THIS HAPPENED WITH, SO BOTH WERE NOTED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SOME UNITS ARE JUST COMING APART WITH NORMAL USE OR SETUP AND NO CAUSE HAVE BEEN IDENTIFIED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE FAULTY PRODUCTS WERE REPLACED IN AN ADDITIONAL SURGERY. IT WAS ALSO REPORTED THAT THE SAME ISSUE OCCURRED MULTIPLE TIMES WITH DIFFERENT PRODUCTS OF THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16809417 ↗
• InjuryMar 29, 2023Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE FAULTY PRODUCTS WERE REPLACED IN AN ADDITIONAL SURGERY. IT WAS ALSO REPORTED THAT THE SAME ISSUE OCCURRED MULTIPLE TIMES WITH DIFFERENT PRODUCTS OF THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16637910 ↗
• InjuryMar 29, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS) USED DURING A PROCEDURE. IT WAS REPORTED THAT THE EXTERNAL VENTRICULAR DRAINAGE IN ICU, SYSTEMS CONTINUE TO FAIL AT THE PROXIMAL PORT CLOSEST TO THE PATIENT. THE PRODUCT WAS DAMAGED. THE SITE WAS NOT SURE WHICH OF THE 2 LOT NUMBERS IN CIRCULATION THIS HAPPENED WITH, SO BOTH WERE NOTED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16637903 ↗
• MalfunctionFeb 22, 2023Break; Disconnection; Fracture; Break; Disconnection; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS). IT WAS REPORTED THAT THE TUBING SEEMED TO BE BREAKING OR SNAPPING OFF AT CERTAIN POINTS, EITHER AT THE CONNECTION CLOSEST TO THE CATHETER OR THE STOPCOCK CLOSEST TO THE PATIENT. IT WAS NOTED THAT THIS HAS BEEN AN ONGOING ISSUE. NO PATIENT IMPACT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419370 ↗
• MalfunctionFeb 8, 2023Break; Disconnection; Fracture; Break; Disconnection; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS) USED DURING AN EXTERNAL VENTRICULAR DRAINAGE IN ICU. IT WAS REPORTED THAT THE CONNECTION WAS ALWAYS EITHER BREAKING OR COMING LOOSE AT THE STOPCOCK OR AT THE LEURLOCK CONNECTED TO THE EVD CATHETER. THE TUBES WERE EITHER BREAKING OR BECOMING DISCONNECTED "AT RANDOM," THERE WAS NO TENSION ON THE LINES NOR WAS THE PATIENT PULLING AT THEIR LINES. IT WAS NOTED THAT THIS WAS THE SECOND OCCURRENCE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330127 ↗
• MalfunctionFeb 8, 2023Break; Disconnection; Fracture; Break; Disconnection; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS) USED DURING AN EXTERNAL VENTRICULAR DRAINAGE IN ICU. IT WAS REPORTED THAT THE CONNECTION WAS ALWAYS EITHER BREAKING OR COMING LOOSE AT THE STOPCOCK OR AT THE LEURLOCK CONNECTED TO THE EVD CATHETER. THE TUBES WERE EITHER BREAKING OR BECOMING DISCONNECTED "AT RANDOM," THERE WAS NO TENSION ON THE LINES NOR WAS THE PATIENT PULLING AT THEIR LINES. IT WAS NOTED THAT THIS WAS THE SECOND OCCURRENCE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328706 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT THE DOCTOR WAS PREPARING THE EXTERNAL DRAINAGE AND MONITORING SYSTEM WHEN THEY REALIZED THE AREA AROUND THE 3 WAY STOP COCK ON THE PATIENT LINE WAS VERY FLIMSY AND SHAKY. BEFORE USING THE DEVICE ON THE PATIENT, WHILE SETTING UP THE DEVICE, ONE SIDE OF THE CONNECTOR BROKE. NO ADVERSE EVENT TOOK PLACE AS THE FAULT WAS FOUND BEFORE BEING USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252895 ↗
• MalfunctionNov 9, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE MAIN SYSTEM STOPCOCK WAS DETACHED FROM THE CLEAR MOUNTING PLASTIC FRAME WHEN THE PRODUCT WAS OPENED. IT WAS NOTED THAT THE SYSTEM COULD NOT BE SET UP PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10813401 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT THE CLIP ON THE MAIN STOPCOCK SYSTEM WAS BROKEN AND WOULD NOT HOLD THE STOPCOCK IN PLACE. THE SYSTEM WAS BROKEN ON 2 DIFFERENT EXTERNAL VENTRICULAR DRAINAGE (EVD) SYSTEMS RIGHT OUT OF THE BOX. ICU ONLY STOCKED 2 SYSTEMS AT ANY GIVEN TIME. THE NURSES NOTICED THE DEFECT DURING PRIMING PRIOR TO ATTACHING TO THE PATIENT. IT WAS NOTED THE NURSES HAD TO BORROW FROM THE OR DURING THE CRISIS SITUATION. IT WAS STATED THAT THIS WAS A PATIENT SAFETY CONCERN AS THE INTRACRANIAL PRESSURE MEASUREMENT WOULD BE INACCURATE AND THE CEREBROSPINAL FLUID MAY DRAIN OUT OF THE PATIENT'S HEAD AT A RAPID RATE WITH A RISK OF MORTALITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10241793 ↗
• MalfunctionDec 20, 2019Break; Break

  IT WAS REPORTED THAT THE EXTERNAL DRAINAGE AND MONITORING SYSTEM WAS NOTED TO HAVE A LARGE CRACK ON EITHER SIDE OF ONE OF THE STOPCOCKS. THE STOPCOCK ITSELF SHOULD BE AFFIXED TO THE SYSTEM BUT WAS BROKEN OFF. IT WAS NOTED THAT THERE WAS NO APPARENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9507342 ↗
• MalfunctionMar 7, 2019Break; Break

  IT WAS REPORTED THAT THE TUBING WAS FOUND KINKED AFTER THE PRODUCT WAS OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8400096 ↗
• MalfunctionMar 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT LINE STOPCOCK WAS NOT WORKING. ACCORDING TO THE REPORT, NOTHING WOULD MOVE WHEN THE STOPCOCK WAS IN THE ¿ON¿ POSITION. REPORTEDLY, THE PRODUCT FAILED DURING SET-UP AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6426501 ↗

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-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-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