NATUS EDS3 COLLECT BAG KIT 5 BAGS NT821733Recalls & reported problems
Natus Medical Incorporated · NATUS EDS3 COLLECT BAG KIT 5 BAGS · 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.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382830050562), received between May 24, 2025 and May 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K061568); 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-0634-2024 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2025Break; Crack; Break; Crack
NT821732C- PATIENT HAD EVD IN PLACE FROM OR. 2 RNS ATTEMPTED TO CHANGE DRAIN BAG AND EXPERIENCED DIFFICULTY IN DISCONNECTING BAG FROM TUBING. ALCOHOL WAS USED TO TRY TO LOOSEN CONNECTION. DRAIN BAG WITH CONTENTS WAS REMOVED FROM HOLDER TO TROUBLESHOOT CONNECTION. AFTER SEVERAL ATTEMPTS, BAG WAS REMOVED FROM TUBING. TUBING WAS ASSESSED AND NO ISSUES NOTED. NEW BAG ATTACHED. RN WENT TO CLEAN CONNECTION WITH CHG AFTER MANIPULATION/CHANGING OF BAG AS EXTRA PRECAUTION DUE TO MULTIPLE ATTEMPTS TO REPLACE BAG. WHEN THE CHG SWAB TOUCHED THE TUBING, THE TUBING IMMEDIATELY BROKE OFF THE BAG. THE MALE END OF THE TUBING BROKE OFF INTO THE FEMALE END OF THE BAG. REQUIRED TUBING CHANGE AT DRAIN SITE BY NEUROSURGERY TEAM, NEW EVD BAG, AND PATIENT STARTED ON ANTIBIOTICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22082042 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K061568. One submission often covers many models, so check the product and lot details in each record.
- Z-0091-2015 · Sep 15, 2014 · TerminatedCodman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar p
- Z-0090-2015 · Sep 15, 2014 · TerminatedCodman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of simil
- Z-0089-2015 · Sep 15, 2014 · TerminatedCodman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of simil
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 · 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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