Becker 46129Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000431259), received between Apr 24, 2024 and Nov 18, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. Nov 1, 2024Open, Classified

   Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

   Z-0661-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE STOPCOCK AREAS WERE LEAKING. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705601 ↗
• MalfunctionSep 23, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE CONNECTION OF THE EXTERNAL VENTRICULAR DRAIN (EVD) BETWEEN THE CHAMBER AND DRAINAGE BAG HAD DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278653 ↗
• MalfunctionSep 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHEN THE NURSE WAS DRAINING THE FLUID INTO THE DRAINAGE BAG, THEY FELT FLUID ON THEIR HAND AS IT WAS LEAKING AT THE CONNECTION. THE PATIENT WAS CLAMPED AT THE TIME SO NO HARM TO THE PATIENT OCCURRED. THE SYSTEM WAS CHANGED TO ANOTHER MANUFACTURER'S DEVICE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189035 ↗
• MalfunctionSep 10, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE 3-WAY CONNECTOR OF THE DRAINAGE FELL OFF DUE TO BEING LOOSELY CONNECTED TO THE DRAINAGE. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184091 ↗
• MalfunctionSep 10, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PROXIMAL CATHETER WAS NOT CONNECTED TO THE 3-WAY TAP AND FELL OUT OF THE PACKAGING DURING OPENING/UNTANGLING OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183872 ↗
• MalfunctionAug 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2024, AND ON (B)(6) 2024, LEAKING WAS REPORTED. THE DEVICE WAS LEAKING AT THE BOTTOM OF THE BURETTE WHERE THE TUBING JOINED THE BASE OF THE BURETTE AND WHERE THE SLIDE CLAMP WAS ON THE TUBING. THE DEVICE WAS REPLACED. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989894 ↗
• MalfunctionAug 9, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE NURSE NOTICED CEREBROSPINAL FLUID (CSF) LEAKING FROM THE COLLECTION CHAMBER OF THE SYSTEM. UPON ASSESSING, CRACKED TUBING WAS NOTED AT THE LEVEL OF THE WHITE CLAMP UNDER THE CSF COLLECTION CHAMBER AND CSF WAS ACTIVELY LEAKING ONTO THE FLOOR. NEUROSURGERY WAS NOTIFIED, AND THE COLLECTION DEVICE HAD TO BE CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949133 ↗
• MalfunctionMay 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE BRAIN FLUID LEAKED FROM THE BOTTOM OF THE DRAINAGE CHAMBER AT THE CONNECTION POINT. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. NO INTERVENTION WAS PERFORMED/PLANNED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE- NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268565 ↗
• MalfunctionApr 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THAT BRAIN FLUID LEAKED FROM THE BOTTOM OF THE DRAINAGE CHAMBER AT THE CONNECTION POINT. THE DEVICE WAS IMMEDIATELY REPLACED WITH ANOTHER ONE. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172314 ↗

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-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
• 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-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-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