NATUS EDS3 DRAINAGE SYSTEM NT821731CRecalls & reported problems
Natus Medical Incorporated · NATUS EDS3 DRAINAGE SYSTEM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Natus EDS3 drainage system is used to drain fluid from around the brain. Most of its 208 reports describe parts breaking, often a cracked or broken stopcock (valve), and some describe fluid leaking. The reports include no deaths or injuries. There is 1 open recall, which began in November 2023 and says sterility cannot be guaranteed because germ testing was incomplete.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 208
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00382830050555), received between Nov 9, 2024 and Aug 28, 2026 — classified as 208 malfunctions.
The most frequently reported specific device problem is “Break” (162 reports).
1 FDA recall record name this device's identifier, 1 still open.
2 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
Recalls naming this device
- Nov 28, 2023Class IIOpen, Classified
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Z-0635-2024 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break162
- Crack25
- Connection Problem15
- Leak/Splash10
- Device Fell4
- Air/Gas in Device2
- Component or Accessory Incompatibility2
- Incomplete or Inadequate Connection2
Patient problems
- No Clinical Signs, Symptoms or Conditions207
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 208 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495117 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495116 ↗MalfunctionAug 25, 2026Break; Crack; Leak/Splash
NT821731C - Natus EVD stopcock cracked. CSF leaked through this crack, leading to inaccurate output and a break in the system. No patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50426397 ↗MalfunctionJun 8, 2026Break
NT821731C - BROKEN STOPCOCK, NO PATIENT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25424748 ↗MalfunctionMay 17, 2026Break
NT821731C - BROKEN STOPCOCK AT BURETROL RENDERING INABILITY TO TURN AND DRAIN FLUID VOLUME HOURLY AS NEEDED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196269 ↗MalfunctionMay 17, 2026Break
THE TRANSDUCER STOPCOCK BROKE REQUIRING THE WHOLE EVD SYSTEM TO BE CHANGED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196257 ↗MalfunctionMay 17, 2026Break
THE TRANSDUCER STOPCOCK BROKE REQUIRING THE WHOLE EVD SYSTEM TO BE CHANGED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196256 ↗MalfunctionMay 17, 2026Break
THE TRANSDUCER STOPCOCK BROKE REQUIRING THE WHOLE EVD SYSTEM TO BE CHANGED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196254 ↗MalfunctionMay 13, 2026Break
NT821731C - STOPCOCK FAILURE. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157952 ↗MalfunctionMay 5, 2026Break
NT821731C - STAFF REPORTED THAT DURING HOURLY ROUND AND CHECKS, ATTEMPTED TO EMPTY FLUIDS FROM THE DRIP CHAMBER AND THE VALVE BROKE. VALVE NOT SEQUESTERED/SAVED. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088025 ↗MalfunctionApr 17, 2026Break
NT821731C - THE EVD BROKE AT THE STOPCOCK TO THE TRANSDUCER DURING ICP CHECKS. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24908844 ↗MalfunctionApr 13, 2026Break; Crack; Leak/Splash
NT821731C - LEAKING FROM A CRACK FOUND ON THE THREE-WAY CLAMP CLOSEST TO THE PATIENT . NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858074 ↗MalfunctionApr 13, 2026Break
NT821731C - THE CUSTOMER REPORTED THAT THE EVD PATIENT LINE STOPCOCK BROKE. A NEW DRAIN WAS PRIMED AND THE BROKEN DRAIN WAS REPLACED. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24855900 ↗MalfunctionApr 10, 2026Break
NT821731C - RED CAP THAT IS ATTACHED TO DRAIN FROM PACKAGING SNAPPED OFF . NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845027 ↗MalfunctionApr 8, 2026Break
NT821731C - WHEN TURNING STOPCOCK, "OFF" PORTION SNAPPED OFF. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24813551 ↗MalfunctionApr 8, 2026Break
NT821731C - PEG OF CAP SNAPPED OFF WITHIN STOPCOCK. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24813550 ↗MalfunctionApr 8, 2026Break
NT821731C - OFF" PORTION OF STOPCOCK BROKE OFF. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24813549 ↗MalfunctionApr 8, 2026Break
NT821731C - EVD STOPCOCK BREAK. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24813548 ↗MalfunctionApr 7, 2026Break
NT821731C - THE EVD BROKE AT THE STOPCOCK TO TRANSDUCER. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799267 ↗MalfunctionMar 25, 2026Break
NT821731C - THE EVD BROKE AT THE STOPCOCK TO TRANSDUCER. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684715 ↗MalfunctionMar 23, 2026Break
(B)(4) - FAILURE OF THE SYSTEM STOPCOCK. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670582 ↗MalfunctionMar 23, 2026Break
NT821731C - DRAIN VALVES ARE BREAKING. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670581 ↗MalfunctionMar 23, 2026Break
NT821731C -STOPCOCK BETWEEN BURETTE AND PATIENT BROKE. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670580 ↗MalfunctionMar 12, 2026Break
NT821731C - EVD STOPCOCK BREAK. IT WAS THE STOPCOCK AT THE TRANSDUCER SITE. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24581267 ↗MalfunctionMar 9, 2026Break
NT821731C - THE STOPCOCK BROKE OFF THE VENTRICULAR DRAIN. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545021 ↗
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-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
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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 · each recall links to the FDA recall notice
- 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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