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N/A 46440Recalls & reported problems

Medtronic Ps Medical, Inc. · KIT 46440 EDM LUMBAR DRAINAGE 5PK · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169466122), received between Jan 3, 2019 and Jan 3, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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

  • Fracture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 3, 2019Fracture; Fracture

    IT WAS REPORTED THE LUMBAR DRAIN WAS PLACED WITHOUT OUTPUT IN THE FIRST HOUR. IT WAS STATED A PORTION OF THE CATHETER WAS FOUND TO BE BROKE OFF IN THE PATIENT. THE CATHETER WAS REMOVED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8212314 ↗

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-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-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

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.