Duet® 46913 (UDI 00613994445360)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00613994445360), received between Aug 10, 2017 and Jan 4, 2024 — classified as 1 death, 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Disconnection” (9 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-1162-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM USED FOR SUBARACHNOID HEMORRHAGE . IT WAS REPORTED THAT THE PATIENT LINE BECAME LOOSE AND FREED ITSELF FROM THE STRAIN RELEASE AT THE LUERLOCK CONNECTOR WHERE THE DEVICE CONNECTED TO THE PATIENT CATHETER CAUSING LEAKAGE. THE DEVICE WAS PLACED ON (B)(6) 2023. THE DEVICE WAS REPLACED ON (B)(6) 2024 AND AGAIN ON THE SAME DAY. THE PATIENT'S STATUS CURRENTLY WAS THEY WERE TOO UNWELL AS THEY WERE UNABLE TO SIT UP OR MOVE.

  Patient problems: Ambulation or Postural Difficulties; Malaise

  MAUDE report 18443551 ↗
• MalfunctionJan 4, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM USED FOR SUBARACHNOID HEMORRHAGE . IT WAS REPORTED THAT THE PATIENT LINE BECAME LOOSE AND FREED ITSELF FROM THE STRAIN RELEASE AT THE LUERLOCK CONNECTOR WHERE THE DEVICE CONNECTED TO THE PATIENT CATHETER CAUSING LEAKAGE. THE DEVICE WAS PLACED ON (B)(6) 2023. THE DEVICE WAS REPLACED ON (B)(6) 2024 AND AGAIN ON THE SAME DAY. THE PATIENT'S STATUS CURRENTLY WAS THEY WERE TOO UNWELL AS THEY WERE UNABLE TO SIT UP OR MOVE.

  Patient problems: Ambulation or Postural Difficulties; Malaise

  MAUDE report 18443517 ↗
• MalfunctionJan 4, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM USED FOR SUBARACHNOID HEMORRHAGE . IT WAS REPORTED THAT THE PATIENT LINE BECAME LOOSE AND FREED ITSELF FROM THE STRAIN RELEASE AT THE LUERLOCK CONNECTOR WHERE THE DEVICE CONNECTED TO THE PATIENT CATHETER CAUSING LEAKAGE. THE DEVICE WAS ORIGINALLY PLACED (B)(6) 2023. THE DEVICE WAS REPLACED ON (B)(6) 2024 AND AGAIN ON (B)(6) 2024. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443293 ↗
• MalfunctionJan 4, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  ADDITIONAL INFORMATION: THE POINT OF DISCONNECTION HAS NOW BEEN CONFIRMED (FOR ALL OCCURRENCES) AT THE PATIENT STOPCOCK DISTAL TO THE PATIENT. THE PATIENT LINE DISCONNECTS FROM THE HARD PLASTIC SLEEVE OF THE STOPCOCK. NURSES HAVE REPORTED SEEING THE LINE 'JUST SLIP OUT'. THIS IS THIRD OCCURRENCE ON THIS PATIENT. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443268 ↗
• MalfunctionApr 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THERE WAS FLUID TRACKING AROUND THE LUER LOCK AT THE EMDS/ CATHETER CONNECTION. THE SITE CHANGED THE EMDS AND THE ISSUE WAS STILL OCCURRING. THEY CHANGED THE CONNECTOR AND ADDED A 3-WAY TAP. THIS RESULTED IN LESS LEAKING. THE EVENT OCCURRED DURING POST OP AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823604 ↗
• MalfunctionApr 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THERE WAS A LEAKAGE ATE THE CATHETER CONNECTION POINT. THE SITE WAS UNSURE IF IT WAS AN ISSUE WITH THE LUER LOCK OR CODMAN CATHETER CONNECTION. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752527 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED THAT AFTER THE DRAINAGE BAG OF THE VENTRICULAR DRAINAGE WAS PLACED, THE DRIP CAVITY BROKE. THE DEVICE WAS REPLACED WITH A NEW ONE OF THE SAME MODEL. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012368 ↗
• MalfunctionOct 27, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT A DISCONNECTION OCCURRED AT THE 3-WAY STOPCOCK AFTER THE SURGERY. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S MEDICAL HISTORY WAS HYDROCEPHALUS. THE PATIENT INJURY DETAILS WAS HOSPITALIZED, AND THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE CAUSE OF THE HOSPITALIZATION AND THE PATIENT'S STATUS OF ALIVE-WITH INJURY WAS NOT DUE TO THE DEVICE. IT WAS STATED THAT IT WAS BECAUSE THE PATIENT HAD A CRANIOTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10741035 ↗
• InjurySep 9, 2020Disconnection; Disconnection

  ADDITIONAL INFORMATION PROVIDED CLARIFICATION THAT "THE CATHETER PROLAPSED AT THE TEE OF THE VENTRICULAR CATHETER" MEANT THAT THE DR AINAGE SYSTEM DISCONNECTED WHERE IT MET THE VENTRICULAR CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10507884 ↗
• InjuryAug 7, 2020Disconnection; Disconnection

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: Coma

  MAUDE report 10382228 ↗
• MalfunctionApr 23, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT THE EXTERNAL VENTRICULAR DRAIN (EVD) TUBING PULLED OUT FROM THE STOPCOCK. IT WAS NOTED THE TUBING IS CEMENTED INTO THE STOPCOCK AND SHOULDN'T PULL OUT. IT WAS UNKNOWN HOW LONG THE DEVICE WAS IN USE BEFORE THE FAILURE OCCURRED. IT WAS STATED THAT THE PATIENT WHO WAS A VERY YOUNG CHILD WAS BEING HELD IN THE PATIENT'S MOTHER'S ARMS AT THE BEDSIDE WHEN THE TUBING PULLED OUT. IT WAS ASKED IF THE MOTHER WAS MOVING AROUND OR WAS THERE ANY EVIDENCE OF THE TUBING GETTING HOOKED ON SOMETHING THAT PUT UNDO TENSION ON IT, AND THE NURSE SAID THEY DID NOT SEE A REASON FOR THIS TO HAPPEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7452738 ↗
• InjuryFeb 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHEN THE PATIENT'S EVD CATHETER WAS ATTACHED IN THE OPERATION ROOM, IT WAS DISCOVERED THAT THE STOPCOCK WAS OBSTRUCTED AND WAS NOT FLOWING PROPERLY THROUGH THE STOPCOCK REGARDLESS OF THE ORIENTATION. THE SYSTEM WAS REPLACED AND IT WAS CONFIRMED THE SECOND UNIT WAS WORKING FINE. THERE WAS A VERY SMALL DELAY IN SURGERY WHILE THE REPLACED THE SYSTEM; HOWEVER, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7258840 ↗
• MalfunctionOct 6, 2017Disconnection; Disconnection

  IT WAS REPORTED THAT THE DEVICE'S MAIN STOP COCK WASN'T GLUED PROPERLY AND FELL OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6919436 ↗
• MalfunctionAug 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DESIGN OF THE DEVICE TO MEASURE INTRACRANIAL PRESSURE HAD THE POTENTIAL TO LEAD TO AN ERROR. ACCORDING TO THE REPORT, THE MEASUREMENT COLUMN ON THE DRAINAGE SYSTEM DEVICE DID NOT HAVE THE ABILITY TO LOCK THE COLUMN ON A UNIT OF MEASURE. THE COLUMN COULD EASILY BE UNKNOWINGLY SWITCHED FROM MMHG TO CMH2O. IT WAS STATED THIS HAD OCCURRED TWO TIMES, ONCE ON (B)(6) 2017 AND ANOTHER TIME ON (B)(6) 2017 WHERE THE CYLINDER MOVED FROM MMHG TO MMH2O ON ITS OWN. REPORTEDLY, THE DEVICE WAS REPLACED WITH ANOTHER DRAINAGE SYSTEM ON (B)(6) 2017. THERE WAS NO PATIENT INJURY, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6799201 ↗
• DeathAug 10, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THERE WAS AN ERROR TURNING OFF THE STOPCOCK TO THE DEVICE BETWEEN THE TRANSDUCER STOPCOCK AND THE DRIP CHAMBER. ACCORDING TO THE REPORT, THE PRIOR SIMILAR EQUIPMENT MANUFACTURED BY ANOTHER MANUFACTURER HAD THE "ON/OFF" STOPCOCK MANIPULATION FOR MONITORING IN THE EXACT OPPOSITE DIRECTION FROM THE REPORTED DEVICE. INCONSISTENCY IN DESIGN BETWEEN THOSE DEVICES WAS A CONTRIBUTING FACTOR TO THE USE ERROR. REPORTEDLY, THE PATIENT DIED ON (B)(6) 2017. THE ORIGINAL INTENDED PROCEDURE WAS FOR INTRACRANIAL FLUID DRAINAGE.

  Patient problems: Death

  MAUDE report 6786585 ↗

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