Duet® 46914 (UDI 00763000624774)Recalls & reported problems
Medtronic Ps Medical, Inc. · EDMS DUET 46914 SMARTSITE SITES · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000624774), received between Dec 18, 2023 and Apr 22, 2024 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Disconnection” (9 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-1163-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Disconnection9
- Fluid/Blood Leak7
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Bacterial Infection1
- Cerebrospinal Fluid Leakage1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2024
RN NOTED THAT EXTERNAL VENTRICULAR DRAINAGE (EVD) TUBING BROKE AND CEREBROSPINAL FLUID WAS FOUND SATURATING LINENS.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 19152246 ↗MalfunctionApr 11, 2024
THE EXTERNAL VENTRICULAR DRAINAGE (EVD) WAS LEAKING AND THE NIPPLE WAS FOUND TO BE CRACKED. REPLACED WITH NEW NIPPLE UNDER STERILE CONDITIONS. POSITIVE CSF CULTURE FOR STREPTOCOCCUS MITIS / ORALIS.
Patient problems: Bacterial Infection
MAUDE report 19087291 ↗MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS). IT WAS REPORTED THAT CEREBROSPINAL FLUID (CSF) LEAKAGE WAS NOTED FROM THE STOPCOCK CONNECTED TO THE EDMS. INCREASED LEAKAGE WAS NOTED WHEN THE STOPCOCK WAS CLAMPED TOWARD THE PATIENT OR TOWARD THE CHAMBER. THE DOCTOR WAS NOTIFIED, AND THE EQUIPMENT WAS CHANGED OUT. NO OTHER DRAINAGE NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046595 ↗MalfunctionMar 7, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHEN CHECKING ON THE PATIENT, WET AREA WAS NOTED ON THE PILLOW BEHIND THE HEAD. THE SYSTEM WAS NOTED TO HAVE BEEN DISCONNECTED AT THE CLEAR PORT PROXIMAL TO THE CATHETER IN THE PATIENT'S HEAD. THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18858155 ↗MalfunctionMar 6, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM SEPARATED AT THE LUER LOCK AND CONNECTING TUBING LEADING TO A RISK OF INFECTION AND RE-INSERTION. THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18850219 ↗MalfunctionMar 6, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM SEPARATED AT THE LUER LOCK AND CONNECTING TUBING LEADING TO A RISK OF INFECTION AND RE-INSERTION. THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18849948 ↗MalfunctionMar 6, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM SEPARATED AT THE LUER LOCK AND CONNECTING TUBING LEADING TO A RISK OF INFECTION AND RE-INSERTION. THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18849815 ↗MalfunctionMar 4, 2024
WHEN CHECKING ON PATIENT, WET AREA NOTED ON PILLOW BEHIND HEAD. EVD WAS NOTED TO HAVE BEEN DISCONNECTED AT CLEAR PORT PROXIMAL TO THE CATHETER IN PATIENT'S HEAD.
Patient problems: Insufficient Information
MAUDE report 18826021 ↗MalfunctionMar 4, 2024
THREE INSTANCES OF EXTERNAL VENTRICULAR DRAINAGE SYSTEMS (EVD) SEPARATING AT THE LUER LOCK AND CONNECTING TUBING LEADING TO A LARGE RISK OF INFECTION AND RE-INSERTION.
Patient problems: Unspecified Infection
MAUDE report 18825982 ↗MalfunctionJan 2, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT LINE CONNECTED TO THE STOPCOCK BROKE. THE DRAINAGE SYSTEM WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18426607 ↗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 18348062 ↗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 18347987 ↗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 18347737 ↗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 18347721 ↗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 18347645 ↗
Other External cerebrospinal fluid (CSF) diversion devices
- Duet® 46915Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion2 recalls1 report
- Duet® 46914Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall7 reports
- Duet® 46916Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall4 reports
- Duet® 46917Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall0 reports
- Duet® 46916Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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