NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER NT821730CRecalls & reported problems
Natus Medical Incorporated · NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382830050548), received between Dec 9, 2024 and Aug 20, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K162437); 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2025Leak/Splash; Leak/Splash
NT821730C - STOPCOCK THAT IS LEAKING CSF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852086 ↗MalfunctionDec 9, 2024Break; Break
NT821730C - STOPCOCK BETWEEN COLLECTION CHAMBER AND BAG BROKE WHEN DRAINING. EVD WAS PLACED (B)(6) (EVENT HAPPENED ON DAY 7 OF DRAIN BEING IN PLACE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20887853 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162437. One submission often covers many models, so check the product and lot details in each record.
- Z-0635-2024 · Nov 28, 2023 · Open, ClassifiedEDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
- Z-0634-2024 · Nov 28, 2023 · Open, ClassifiedExternal Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
- Z-1143-2021 · Jan 12, 2021 · TerminatedRef: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid
Other Shunt, Central Nervous System And Components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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