CODMAN EDS 3 82-1731Recalls & reported problems
Cerenovus, Inc. · CODMAN EDS 3 CSF External Drainage System · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886704040910), received between Jan 24, 2019 and Feb 15, 2019 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Disconnection” (6 reports).
6 other recalls cover devices cleared under the same FDA submission (K061568, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Disconnection6
- Crack1
- Failure to Disconnect1
- Fluid/Blood Leak1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient6
- Air Embolism1
- Cerebrospinal Fluid Leakage1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2019Disconnection; Disconnection
TUBING BECAME DISCONNECTED FROM BURETTE CHAMBER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345871 ↗MalfunctionFeb 15, 2019Disconnection; Disconnection
STOPCOCK DISCONNECTED FROM TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345844 ↗MalfunctionFeb 15, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
EDS III LEAKED AT 3-WAY STOP COCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345691 ↗MalfunctionFeb 15, 2019Disconnection; Disconnection
EDS III LEAKED AT CONNECTION AND WOULD NOT DRAIN INTO THE COLLECTION BAG.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345599 ↗MalfunctionFeb 15, 2019Obstruction of Flow; Obstruction of Flow
INADEQUATE DRAINAGE AT DRIP CHAMBER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345407 ↗MalfunctionFeb 15, 2019Disconnection; Disconnection
DISCONNECTION OF MALE TERMINATION WITH SYSTEM WAS FRACTURED, CAUSING DRAINAGE SYSTEM TO BECOME DISCONNECTED AT THE VENTRICULAR CATHETER FROM THE TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345394 ↗MalfunctionFeb 15, 2019Disconnection; Disconnection
EDS3 DID NOT ADEQUATELY DRAIN, SO ANOTHER WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 8345306 ↗InjuryJan 29, 2019Crack; Crack
CONNECTION TO THE PATIENT BECAME CRACKED, ALLOWING AIR INTO THE SYSTEM AND INTERCRANIAL VENTRICLES.
Patient problems: Air Embolism
MAUDE report 8287371 ↗MalfunctionJan 24, 2019Failure to Disconnect; Failure to Disconnect
EDS3 LEAKED FLUID FROM THE THREE WAY TAP FOLLOWING PATIENT BEING ROLLED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 8274764 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K061568, 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-0635-2024 · Nov 28, 2023 · Open, ClassifiedEDS 3 CSF External Drainage System, REF: NT821731C, 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
- 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-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-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
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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