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Becker® 46124 (UDI 00673978228730)Recalls & reported problems

Medtronic Ps Medical, Inc. · BAG 46124 BECKER DRAINAGE EDMS · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00673978228730), received between Jun 17, 2021 and Aug 12, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 reports).

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.

Most reported problems

Device problems

  • Infusion or Flow Problem3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 12, 2021Infusion or Flow Problem; Infusion or Flow Problem

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12313928 ↗
  • MalfunctionJun 17, 2021Infusion or Flow Problem; Infusion or Flow Problem

    IT WAS REPORTED THE DRAINAGE BAG COULD NOT DRAIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12017550 ↗
  • MalfunctionJun 17, 2021Infusion or Flow Problem; Infusion or Flow Problem

    IT WAS REPORTED THE DRAINAGE BAG COULD NOT DRAIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12017512 ↗

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-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-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
  • 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-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

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Sources and updates

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