Becker® 46129 (UDI 00673978228761)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00673978228761), received between Mar 17, 2017 and Feb 2, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AT 2100 HOURS ON (B)(6) 2017, THE CEREBROSPINAL FLUID (CSF) WAS OSCILLATING, BUT NOT DRAINING INTO THE CHAMBER. THE INTRACRANIAL PRESSURE (ICP) WAVEFORM WAS GOOD. FIFTEEN MINUTES LATER, THE DOCTOR WITHDREW THE EXTERNAL VENTRICULAR DRAIN (EVD) BY 1 CM AND RE-STITCHED. THE CSF WAS STILL OSCILLATING AND NOT DRAINING. THE DOCTOR THEN TRIED ASPIRATING AND FLUSHING FROM THE 3-WAY CONNECTOR TO THE CHAMBER AND WAS SUCCESSFUL. HOWEVER, WHEN THEY TURNED THE 3-WAY CONNECTOR TO DRAIN FROM PATIENT, THE PRESSURE WAS HIGH, AND CSF WAS FLOWING OUT AT A HIGH FLOW RATE. THE DOCTOR MANAGED TO ASPIRATE ABOUT 15 ML FROM THE PATIENT AT THE 3-WAY CONNECTOR. WHEN TURNING THE 3-WAY (PATIENT TO CHAMBER), CSF WAS BACKFLOWING. WHEN THE EVD WAS BROUGHT AT A LOWER HEIGHT, THE CSF WAS OSCILLATING AND NOT DRAINING. THE DOCTOR SUSPECTED THE EVD SYSTEM WAS FAULTY AND REQUESTED THE NURSES TO CHANGE THE DRAINAGE BAG. BETWEEN 2130-2145 HOURS, THE EVD DRAINAGE BAG WAS CHANGED, BUT THE SYSTEM WAS STILL NOT DRAINING CSF INTO THE CHAMBER. THE ISSUE WAS ATTEMPTED TO BE RECTIFIED BY SCRUBBING, THEN ASPIRATING FROM THE Y-SITE CONNECTOR BELOW THE CHAMBER. THEY COULD ASPIRATE SLIGHTLY, HOWEVER CSF WAS STIL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7236062 ↗
• MalfunctionMar 17, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE SYSTEM DID NOT DRAIN INTRA-OPERATIVELY. ACCORDING TO THE REPORT, THE SYSTEM WAS CHANGED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6415492 ↗

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-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
• 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