Duet® 46914 (UDI 00763000395971)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000395971), received between Dec 20, 2022 and Feb 19, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

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

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT A SIMILAR EVENT TO THE FOLLOWING OCCURRED AT THE END OF JANUARY: WHILE MONITORING AND DRAINING CEREBROSPINAL FLUID (CSF) WITH THE SYSTEM, THE DOCTOR FOUND THAT THERE WAS A CSF LEAK FROM THE PATIENT LINE. IT WAS NOTED THAT THE LEAK PROBABLY CAME FROM A CONNECTION FAULT FROM THE STOPCOCK ON THE PATIENT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730734 ↗
• MalfunctionFeb 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHILE MONITORING AND DRAINING CEREBROSPINAL FLUID (CSF) WITH THE SYSTEM, THE DOCTOR FOUND THAT THERE WAS A CSF LEAK FROM THE PATIENT LINE. IT WAS NOTED THAT THE LEAK PROBABLY CAME FROM A CONNECTION FAULT FROM THE STOPCOCK ON THE PATIENT LINE. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S DEVICE. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730661 ↗
• MalfunctionJan 23, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Device Dislodged or Dislocated; Fluid/Blood Leak; Loose or Intermittent Connection; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DRAIN WAS INSERTED ON (B)(6) 2023, AND THE NURSES FOUND OUT THAT PATIENT LINE CONNECTED TO THE 3 WAY STOP COCK WAS LOOSE AND CEREBROSPINAL FLUID CSF WAS SEEPING OUT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564027 ↗
• MalfunctionJan 23, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Device Dislodged or Dislocated; Fluid/Blood Leak; Loose or Intermittent Connection; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DRAIN WAS INSERTED ON (B)(6) 2024, AND ON (B)(6) 2024, THE NURSE FOUND THAT THE PATIENT LINE CONNECTED TO THE 3 WAY STOP COCK WAS LOOSE AND ROTATABLE. CEREBROSPINAL FLUID (CSF) WAS SEEPING OUT OF THE GAP. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563898 ↗
• MalfunctionJan 19, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Device Dislodged or Dislocated; Fluid/Blood Leak; Loose or Intermittent Connection; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS INSERTED ON JANUARY 1ST, 2024, AND ON JANUARY 18, 2024, THE NURSE FOUND LEAKING OF CEREBROSPINAL FLUID (CSF) TO THE BEDSHEET. TROUBLESHOOTING FOUND A LOOSE CONNECTION ON THE STOPCOCK. IT WAS ATTEMPTED TO BE PUSHED IN BUT STILL LEAKED AFTER 1-2 HOURS. THE SYSTEM WAS REMOVED AS THE PATIENT WAS DUE FOR A VENTRICULOPERITONEAL SHUNT SURGERY. THE PATIENT WAS DOING WELL SO FAR AFTER THE SHUNT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543029 ↗
• MalfunctionFeb 23, 2023Break; Disconnection; Fluid/Blood Leak; Fracture; Break; Disconnection; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE SYSTEM. IT WAS STATED THAT WHILE IN USE, CONNECTED TO A PATIENT, THE TUBING FROM THE DRAINAGE SYSTEM BECAME DISLODGED AT THE CONNECTION POINT. THIS CAUSED A CLOSED SYSTEM BREACH, EXPOSING THE PATIENT TO A RISK OF INFECTION. ADDITIONALLY, THIS CAUSED IMPROPER DRAINAGE OF THE CEREBROSPINAL FLUID (CSF) DUE TO THE BREACH OF THE DRAINAGE SYSTEM. THE SITE WAS UNSURE HOW LONG THE SYSTEM WAS BREACHED BEFORE THE BROKEN CONNECTION POINT WAS FOUND. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT DURING PATIENT CARE, WHILE CATHETER IN USE, THE SYSTEM WAS FOUND BROKEN IN HALF/COMPLETELY DISCONNECTED FROM THE SYSTEM JUST BELOW PROXIMAL STOPCOCK. THE SITEREPLACED THE DISLODGED TUBING,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430126 ↗
• MalfunctionDec 20, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE PART OF THE DEVICE THAT WAS THE ISSUE WAS EXTERNAL AND WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014662 ↗