Duet® 46913 (UDI 00763000624767)Recalls & reported problems
Medtronic Ps Medical, Inc. · EDMS 46913 DUET INTERLINK SITES · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Duet 46913 external ventricular drain is a tubing-and-catheter system that drains and monitors fluid pressure around the brain. Its reports mostly describe the tubing coming apart or leaking at the three-way stopcock connection, and sometimes cracking or breaking near the access site, which can let fluid escape. There are 58 reports, with1 injury and no deaths. One recall, opened in January 2024 and still open, concerns the catheter potentially disconnecting from the patient line stopcock connectors; the company is still investigating.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 58
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00763000624767), received between May 31, 2023 and Apr 30, 2025 — classified as 1 injury, 57 malfunctions.
The most frequently reported specific device problem is “Disconnection” (52 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Disconnection52
- Fluid/Blood Leak46
- Break5
- Fracture5
- Device Dislodged or Dislocated1
- Infusion or Flow Problem1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions57
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT REQUIRED AN EXTERNAL VENTRICULAR DRAIN (EVD), AND THE DRAIN THAT WAS USED WAS DEFECTIVE CAUSING AN ISSUE WITH THE PATIENT. THE HEALTHCARE PROFESSIONAL (HCP) STATED THEY RECEIVED THE DEVICE FROM AN AFFILIATED HOSPITAL IN WHICH WAS CRACKED. THE PATIENT LOST 100 MILLILITERS OF CEREBROSPINAL FLUID. AS A RESULT, THE PATIENT RECEIVED A SHUNT. THE HCP CONVEYED THE PATIENT WAS DOING OK AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 21936365 ↗MalfunctionFeb 15, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE TUBING DISCONNECTED FROM THE THREE-WAY STOPCOCK REQUIRING THE SYSTEM TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18711232 ↗MalfunctionFeb 2, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBING ATTACHED TO THE LUMBAR DRAIN DETACHED AT THE STOPCOCK REQUIRING A DRAIN SYSTEM REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18634666 ↗MalfunctionJan 29, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2024, AN EXTERNAL VENTRICULAR DRAIN (EVD) CATHETER WAS FOUND TO BE BROKEN NEAR THE PROXIMAL ACCESS SITE. NURSING AND PHYSICIAN LEADS WERE NOTIFIED, AND IT APPEARED AS IF THE DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18595688 ↗MalfunctionJan 5, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING NORMAL CHECK OF THE PATIENT WITH THE DEVICE, THE PATIENT LINE DISCONNECTED OR WAS FOUND TO BE DISCONNECTED FROM THE STOPCOCK. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18456094 ↗MalfunctionJan 4, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHILE CHECKING THE PATIENT, THE PATIENT LINE DISCONNECTED FROM THE STOPCOCK. THE DEVICE WAS REPLACED. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443893 ↗MalfunctionJan 2, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE PATIENT WAS SETUP WITH THE DEVICE AND CONTINUOUSLY MONITORED. AT SOME POINT, THE LINE BY THE STOPCOCK BROKE WHERE THE TUBING WAS SEPARATING FROM THE PIECE IT SHOULD BE CONNECTED TO. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 15 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18427484 ↗MalfunctionDec 21, 2023Break; Fracture; Break; Fracture
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS REPLACED WITH THE SAME MODEL NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18372847 ↗MalfunctionDec 21, 2023Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE HAD TUBING THAT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18372815 ↗MalfunctionDec 18, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18347448 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320452 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320392 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320323 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320269 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320173 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320071 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320014 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319931 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319894 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319846 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319804 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319661 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319630 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319607 ↗MalfunctionDec 13, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO THE RECENT FAILURES OF LEAKING AND THE PATIENT LINE COMING APART FROM THE STOPCOCK, THE SITE WAS RELUCTANT TO CONTINUE TO USE THE DEVICES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319501 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.