CODMAN EDS 3 82-1730Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704040903), received between Dec 29, 2017 and Aug 23, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (3 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED BY AN INTERNATIONAL USER FACILITY: "AFTER 4 DAYS AN EDS3 STARTED LEAKING. IT WAS REPLACED BY ANOTHER EXTERNAL DRAIN. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM". PATIENT INFORMATION: N/A. PATIENT IS NOT PART OF A CLINICAL STUDY. NO SURGICAL DELAY REPORTED. THIS IS NOT A REVISION OF ONE OR MORE IMPLANTS. ON (B)(6) 2018: THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7809479 ↗
• MalfunctionJun 21, 2018Leak/Splash; Leak/Splash

  THE FOLLOWING WAS REPORTED BY CODMAN TO NATUS ON 31MAY2018: "AS REPORTED BY THE OUS AFFILIATE, AN EDS III WAS LEAKING AT THE 3 WAY STOP COCK. ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM." THIS IS NOT A REVISION OF ONE OR MORE IMPLANTS. PATIENT IS NOT PART OF A CLINICAL TRIAL. PATIENT INFORMATION: NO INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7626321 ↗
• MalfunctionJun 21, 2018Leak/Splash; Leak/Splash

  THE FOLLOWING WAS REPORTED BY CODMAN TO NATUS ON 31MAY2018: "AS REPORTED BY THE OUS AFFILIATE, AN EDS III WAS LEAKING. ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM." THE DEVICE WILL NOT BE RETURNED. THIS IS NOT A REVISION OF ONE OR MORE IMPLANTS. PATIENT IS NOT PART OF A CLINICAL STUDY. EVENT DATE (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625757 ↗
• MalfunctionMay 3, 2018Material Integrity Problem; Material Integrity Problem

  AS REPORTED ON AN EXCEL SPREADSHEET RECEIVED FROM CODMAN "AN EDSIII, 821730, ATTACHED TO AN EVD DRAIN, DEVELOPED A CRACK DEVELOPED AT THE ACCESS PORT AND THE DRAIN WAS REMOVED. IT WAS NOTED THAT THE DRAIN WAS NOT LONGER DRAINING AND THERE WAS AIR IN THE DRAIN LINE. THE NEUROSURGICAL REGISTRAR REVIEWED THE DRAIN AND ATTEMPTED TO FLUSH THE DRAIN WITH SALINE. THE REGISTRAR NOTED THAT SALINE WAS SQUIRTING OUT THROUGH THE CRANIAL PORT,( THE ACCESS PORT OF THE DRAIN CLOSEST TO THE PATIENT). A CRACK WAS NOTED AT THE ACCESS PORT. A ROUTINE CT SCAN WAS PERFORMED AS THE DRAIN WAS NOT FUNCTIONING, AND IT WAS NOTED THAT NEW INTRAVENTRICULAR GAS WAS SEEN. THE DRAIN WAS REMOVED ON THE (B)(6) 2018. NO ADVERSE EVENT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7484991 ↗
• MalfunctionMay 2, 2018Device Operational Issue; Device Operational Issue

  AS REPORTED ON AN EXCEL SPREADSHEET RECEIVED FROM CODMAN "AN ICP WOULD NOT DRAIN. THE TUBING WAS PURGED BY SUCTION AT THE PROXIMAL VALVE WITH A SYRINGE. THERE WERE NO REPORTS OF PATIENT HARM". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7480787 ↗
• MalfunctionMar 29, 2018Leak/Splash; Leak/Splash

  AS REPORTED ON A SPREADSHEET RECEIVED BY NATUS ON (B)(6) 2018, AN EDS3 (EXTERNAL DRAINAGE SYSTEM) LEAKED AT THE PROXIMAL STOPCOCK. REPLACED WITH ANOTHER; HOSPITALIZATION OF PATIENT WAS EXTENDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7383045 ↗
• MalfunctionDec 29, 2017Device Operational Issue; No Flow; Pressure Problem; Device Operational Issue

  FROM MS EXCEL SPREADSHEET PROVIDED BY INTEGRA LIFESCIENCES ON 04 DEC 2017: "WHEN ATTEMPTING TO DRAIN THE SYSTEM, IT DOES NOT DRAIN, IT DOES NOT APPLY PRESSURE TO TAKE A PIC CURVE. THE SPECIALIST SAYS THAT THE DRAINAGE SYSTEM DOES NOT WORK ITS KEYS, DOES NOT ALLOW DRAINAGE TO BURETROL OR INTRACRANIAL PRESSURE INTAKE. THEY CHANGED THE DRAINAGE SYSTEM AND THE SAME THING HAPPENED; THE SPECIALIST SAID THAT WHEN TURNING THE BURETROL KEY TO PERFORM THE DRAINAGE, IT DOES NOT DRAIN AND THE KEY TO CONNECT THE PIC MONITOR SENSOR DOES NOT MAKE THE CURVE WITHOUT LIQUID PRESSURE. THE SPECIALIST SHOWS US HOW HE USES THE PRODUCT AND DOES IT AN ADEQUATE WAY WITH 20 YEARS OF KNOWLEDGE IN DRAINS AND PIC MONITORING." REFERENCE 2023988-2017-00517 FOR MDR CREATED FOR THE FIRST OR INITIAL DEVICE USED WITH PATIENT AS DESCRIBED IN THE COMPLAINT DESCRIPTION ABOVE. ALSO STATED IN THE REPORT REFERENCED ABOVE: "COMPLAINT CATEGORY - CODMAN: NO REPORTED PATIENT/USER HARM" A REQUEST WILL BE MADE TO OBTAIN DEVICE INFORMATION AS WELL AS MORE INFORMATION RELATED TO THE PATIENT AS WELL AS THE POTENTIAL IMPACT THE DELAY IN PATIENT CARE MAY HAVE HAD ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7155520 ↗
• MalfunctionDec 29, 2017Device Operational Issue; No Flow; Pressure Problem; Device Operational Issue

  FROM MS EXCEL SPREADSHEET PROVIDED BY INTEGRA LIFESCIENCES ON (B)(6) 2017: "WHEN ATTEMPTING TO DRAIN THE SYSTEM, IT DOES NOT DRAIN, IT DOES NOT APPLY PRESSURE TO TAKE A PIC CURVE. THE SPECIALIST SAYS THAT THE DRAINAGE SYSTEM DOES NOT WORK ITS KEYS, DOES NOT ALLOW DRAINAGE TO BURETROL OR INTRACRANIAL PRESSURE INTAKE. THEY CHANGED THE DRAINAGE SYSTEM AND THE SAME THING HAPPENED; THE SPECIALIST SAID THAT WHEN TURNING THE BURETROL KEY TO PERFORM THE DRAINAGE, IT DOES NOT DRAIN AND THE KEY TO CONNECT THE PIC MONITOR SENSOR DOES NOT MAKE THE CURVE WITHOUT LIQUID PRESSURE. THE SPECIALIST SHOWS US HOW HE USES THE PRODUCT AND DOES IT IN AN ADEQUATE WAY WITH 20 YEARS OF KNOWLEDGE IN DRAINS AND PIC MONITORING." REFERENCE 2023988-2017-00518 FOR MDR CREATED FOR THE SECOND DEVICE TRIED AS MENTIONED IN THE COMPLAINT DESCRIPTION ABOVE. ALSO STATED IN THE REPORTED REFERENCED ABOVE: "COMPLAINT CATEGORY - CODMAN: NO REPORTED PATIENT/USER HARM". A REQUEST WILL BE MADE TO OBTAIN DEVICE INFORMATION AS WELL AS MORE INFORMATION RELATED TO THE PATIENT AS WELL AS THE POTENTIAL IMPACT THE DELAY IN PATIENT CARE MAY HAVE HAD ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7155120 ↗

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-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
• 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