Becker 46128Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000406073), received between Sep 9, 2024 and Apr 20, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PRODUCT RUPTURED. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931962 ↗
• MalfunctionAug 25, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT 3 DEVICES IN A ROW FAILED IN THE OPERATING ROOM AS THE CONNECTOR WAS CRACKED. A 4TH DEVICE WAS OPENED AND SUCCESSFULLY USED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882646 ↗
• MalfunctionAug 25, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT 3 DEVICES IN A ROW FAILED IN THE OPERATING ROOM AS THE CONNECTOR WAS CRACKED. A 4TH DEVICE WAS OPENED AND SUCCESSFULLY USED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882640 ↗
• MalfunctionFeb 19, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE LUMBAR DRAIN WAS FOUND SNAPPED OFF AT THE TUBING PROXIMAL TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410439 ↗
• MalfunctionJan 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DRAIN WAS SWITCHED OUT DUE TO SAFETY RISK INCLUDING RISK OF HERNIATION FROM EXCESSIVE CSF LEAK AND INFECTION. THE PATIENT'S CURRENT STATUS WAS DECEASED, HOWEVER, THE FAMILY MADE THE DECISION TO WITHDRAW LIFE-SUSTAINING MEASURES PER THE PATIENT'S ADVANCED DIRECTIVE, AND THEIR COMPLEX DIAGNOSES (ANEURYSM RUPTURE, MULTI ORGAN FAILURE) WERE NOT RELATED TO THE MEDICAL DEVICE AND/OR THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147547 ↗
• MalfunctionOct 18, 2024Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE COLLECTION BAG ON THE LUMBAR DRAIN WAS DUE FOR A CHANGE. THE LUER LOCK WHERE THE COLLECTION BAG CONNECTED TO THE DRAIN TUBING WAS STUCK, AND THE BAG SNAPPED OFF THE TUBING WITH THE LUER LOCK STILL STUCK. THE SITE WAS UNABLE TO DETACH THE LUER LOCK FROM THE REST OF THE SYSTEM. THE DEVICE WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480497 ↗
• MalfunctionSep 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THERE WAS WATER LEAKAGE JUST BELOW THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181485 ↗
• MalfunctionSep 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THERE WAS WATER LEAKAGE BETWEEN THE DRIP CHAMBER AND DRAINAGE BAG. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181037 ↗
• MalfunctionSep 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THERE WAS WATER LEAKAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180913 ↗
• MalfunctionSep 9, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WERE 2 CLAMPS BETWEEN THE FLOW CHAMBER AND THE BAG. TOP OF THE CLAMP CAME OUT AND DISCONNECTED. THE NURSE CLEANED THE BOTTOM OF THE TUBE AND RECONNECTED AND ESCALATED TO THE NEUROSURGERY RESIDENT ON CALL. THE RESIDENT ON CALL STATED IT WAS OKAY NOW BUT TO MENTION TO THE DOCTOR ON ROUNDS. THEN, LEAKING WAS NOTICED AT THE DISTAL ACCESS SITE BY THE DAY SHIFT NURSE BETWEEN THE BURETROL AND BAD. THE NEUROSURGERY TEAM WAS NOTIFIED, AND THE SYSTEM WAS CHANGED. THERE WAS A PROCEDURE DELAY OF 30 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 20168770 ↗

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-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
• 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-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-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