Becker System 26040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000406066), received between Dec 2, 2024 and Nov 17, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THERE WAS A LEAK AT THE VALVE (UNDER THE VALVE OF THE EXTERNAL VENTRICULAR DRAIN (EVD)). IT WAS NOTICED BECAUSE CEREBROSPINAL FLUID (CSF) WAS SPOTTED IN THE BED BY THE NEUROSURGEON FOR CAT IN THE EMERGENCY. AN EVD NEEDED TO BE RE-INSTALLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569373 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DRAIN WAS LEAKING. THE DRAIN WAS REPLACED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299694 ↗
• MalfunctionMar 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE BAG WAS LEAKING FLUID. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505414 ↗
• MalfunctionJan 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING. IT WAS REPORTED THERE WAS LEAKING OF THE EXTERNAL VENT RICULAR BYPASS CIRCUIT IN THE BURETTE WHILE IN THE PATIENT'S CARE. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071641 ↗
• MalfunctionJan 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING. IT WAS REPORTED THERE WAS LEAKING OF THE EXTERNAL VENTRICULAR BYPASS CIRCUIT IN THE BURETTE WHILE IN THE PATIENT'S CARE. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071619 ↗
• MalfunctionDec 2, 2024Loose or Intermittent Connection; Device Dislodged or Dislocated; Infusion or Flow Problem; Loose or Intermittent Connection; Device Dislodged or Dislocated; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD AN EXTERNAL VENTRICULAR DRAIN (EVD) PLACED IN THE OPERATING ROOM, HOWEVER, THE DRAINAGE SYSTEM HAD TO BE CHANGED OUT FOR ANOTHER MANUFACTURER'S DEVICE. IT WAS STATED THAT THE DRAINAGE SYSTEM WAS NOT A DEVICE THAT COULD BE SECURED WELL TO THE IV POLE LIKE THE OTHER SYSTEMS. THE DEVICE HANGS FROM THE TOP OF THE POLE, AND THE STAFF HAS TO CREATIVELY SECURE IT. THE BURETTE PORTION OF THE SYSTEM BEING USED FOR THIS PARTICULAR PATIENT BECAME LOOSE AND WAS NOT ABLE TO BE TIGHTENED TO MAINTAIN THE ORDERED LEVEL PER THE PROVIDER ORDER. THIS CREATED AN UNSAFE SITUATION FOR THE PATIENT, AND THE DRAINAGE SYSTEM WAS DISCONNECTED AND REPLACED BY THE NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20823236 ↗

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-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-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-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-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