CODMAN EDS 3 82-1738Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704040958), received between Jan 15, 2018 and Jan 11, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2019Failure to Disconnect; Failure to Disconnect

  DRAINAGE BAG BROKE OFF AT THE LUER LOCK CONNECTION SITE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8241534 ↗
• MalfunctionJun 14, 2018Device Operational Issue; Device Operational Issue

  CODMAN REPORTED THE FOLLOWING TO NATUS ON (B)(6) 2018: "AS REPORTED BY THE OUS AFFILIATE, AN EDS 3 WILL NOT DRAIN CSF FORM THE COLLECTION CHAMBER TO THE DRIP BAG. SURGEON IS CONTINUOUSLY ASPIRING THE CHAMBER TO REDUCE THE CSD COLLECTION WHILE HE WAITS FOR A REPLACEMENT EDS3. THERE WERE NO REPORTS OF ADDITIONAL PATIENT HARM." WAS THE SURGERY DELAYED: NO. IS THIS A REVISION OF ONE OR MORE IMPLANTS: NO. NO REPORTED PATIENT OR USER HARM. NO FURTHER INFORMATION WAS PROVIDED IN RELATION TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601305 ↗
• MalfunctionMay 2, 2018Leak/Splash; Leak/Splash

  AS REPORTED ON AN EXCEL SPREADSHEET RECEIVED FROM CODMAN "AN EDSIII WAS LEAKING AT THE 3 WAY STOPCOCK. THE DRAIN WAS CHANGED IMMEDIATELY. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM". ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7480889 ↗
• MalfunctionJan 15, 2018Leak/Splash; Leak/Splash

  NATUS BECAME AWARE OF THE FOLLOWING COMPLAINT INFORMATION (B)(6) 2017: "AS REPORTED BY THE OUS AFFILIATE, AN EDS III WAS LEAKING AROUND THE 3 WAY TAP., POST OPERATIVELY. ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED DELAY OR PATIENT HARM." AS NO FURTHER INFORMATION WAS PROVIDED RELATED TO THE PATIENT OR THE SPECIFIC DEVICE (SUCH AS LOT NUMBER), ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7190561 ↗

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, Classified
  External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
• Z-0635-2024 · Nov 28, 2023 · Open, Classified
  EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
• Z-1143-2021 · Jan 12, 2021 · Terminated
  Ref: 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-0089-2015 · Sep 15, 2014 · Terminated
  Codman 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
• Z-0090-2015 · Sep 15, 2014 · Terminated
  Codman 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 · Terminated
  Codman 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