CODMAN® EDS3™ 821730CRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10381780521020), received between Mar 29, 2022 and May 1, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056070 ↗
• MalfunctionSep 5, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED A LEAK IN THE TUBING OF AN EXTERNAL DRAINAGE SYSTEM (ID 821730C). THEREFORE, THE PRODUCT WAS REPLACED. THE PRODUCT PROBLEM WAS DISCOVERED AFTER A PROCEDURE. THE EDS WAS PLACED IN THE BEDSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977783 ↗
• MalfunctionAug 18, 2025Use of Device Problem; Improper Flow or Infusion; Use of Device Problem; Improper Flow or Infusion

  NA.

  Patient problems: Headache; Pneumocephalus

  MAUDE report 22828632 ↗
• MalfunctionApr 17, 2025Disconnection; Disconnection

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 21857733 ↗
• MalfunctionMar 28, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE ABOVE LUER LOCK OF THE EXTERNAL DRAINAGE SYSTEM (ID (B)(6)) WAS BROKEN, AND CEREBROSPINAL FLUID (CSF) WAS LEAKING ONTO THE FLOOR WHILE EMPTYING THE COLLECTION RESERVOIR OF THE EXTERNAL VENTRICULAR DRAIN (EVD). ALL OTHER CONNECTIONS REMAINED INTACT. DUE TO THE LOCATION OF THE BREAK, THE ENTIRE EVD SYSTEM NEEDED TO BE REPLACED, NOT JUST THE COLLECTION BAG. THE TWO BROKEN SECTIONS WERE SECURED WITH WATERPROOF TAPE TO MAINTAIN AS MUCH STERILITY AS POSSIBLE. THE DRAIN WAS REMOVED AT THE BEDSIDE, AND THE SITE WAS SUTURED CLOSED. THE TIP OF THE CATHETER AND CSF WERE SENT FOR CULTURE, AND WHILE AWAITING RESULTS, THE PATIENT RECEIVED THREE DAYS OF INTRAVENOUS VANCOMYCIN AND FLUCONAZOLE. THE CULTURES RETURNED POSITIVE FOR CONTAMINATION. A FACILITY REPORTED: "WHEN EMPTYING THE COLLECTION RESERVOIR OF THE EXTERNAL VENTRICULAR DRAIN (EVD) OF 68-YEAR-OLD PATIENT, CEREBROSPINAL FLUID (CSF) NOTED TO BE LEAKING ON THE FLOOR. ON CLOSER INSPECTION, THE EVD WAS NOTED TO BE BROKEN ABOVE THE LUER LOCK WHERE THE BAG CAN BE CHANGED. ALL OTHER CONNECTIONS REMAINED INTACT. DUE TO THE PLACEMENT OF THE BREAK, THE ENTIRE EVD SYSTEM WOULD NEED TO BE REPLACED (NOT JUST THE COLLECTION

  Patient problems: Insufficient Information

  MAUDE report 21721035 ↗
• MalfunctionFeb 4, 2025Component Missing; Component Missing

  A FACILITY REPORTED: "DURING AN EMERGENCY SURGICAL PROCEDURE PERFORMED ON A PATIENT WITH A DIAGNOSIS OF SERIOUS ILLNESS, SUBARANOID INTRAVENTRICULAR HEMORRHAGE OF ANEURYSMAL ORIGIN WITH ACUTE HYDROCEPHALUS, THE CODMAN EXTERNAL DRAINAGE SYSTEM (ID 821730C) IS OPENED TO BE USED AND THE ABSENCE OF THE DEVICE TO FIX THE DRAINAGE SYSTEM IS EVIDENT. HOWEVER, DUE TO THE URGENCY, IT IS FIXED ONLY WITH SUTURE, WHICH AT THE END OF THE SURGICAL PROCESS, THE SYSTEM COMES OFF AND IT IS NOT POSSIBLE TO REOPERATE ON THE PATIENT." ADDITIONAL INFORMATION RECEIVED: "THE PATIENT DIED DUE TO HER CRITICAL CONDITION" AND CONFIRMED BY THE DISTRIBUTOR: "THE DEVICE FAILURE WAS NOT THE CAUSE OF THE DEAD OF THE PATIENT."

  Patient problems: Insufficient Information

  MAUDE report 21306616 ↗
• MalfunctionJan 28, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THE CAP OF A CONNECTOR OF AN EVD: EXTERNAL DRAINAGE SYSTEM (ID 821730C) BROKE WHILE CHANGING THE BAG . THEREFORE, ON (B)(6) 2024 A NEW EVD SYSTEM WAS PRIMED AND CONNECTED TO THE PATIENT AT THE BEDSIDE. ONCE THE NEW SYSTEM WAS ATTACHED THE STAFF NOTICED THAT THERE WAS CSF LEAKING ON THE FLOOR AND BAG OF SYSTEM. UPON INSPECTION, THE SYSTEM WAS CONFIRMED TO BE SECURELY CONNECTED; HOWEVER, IT WAS DETERMINED THAT THE BAG ITSELF WAS LEAKING. AS A RESULT, A NEW BAG WAS CONNECTED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255276 ↗
• InjuryJan 7, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED: "WHEN NURSE TOOK OVER AT 7 PM, THE PATIENT'S EVG WAS CLOGGED AGAIN (THIS HAD ALREADY HAPPENED MANY TIMES AND WAS UNCLOGGED WITH ACTILYSIS AND WATER FOR INJECTION) - THEREFORE NON-PERMEABLE AND NONREACTIVE INFERIOR INTERMEDIATE PUPILS (KNOWN). ATTEMPT TO UNBLOCK AT 9PM WITH ACTILYSE (WHICH HAD ALREADY TAKEN PLACE AT 6PM WITH WATER FOR INJECTION) THEN CLAMPING FOR 2H (ON ORAL MEDICAL REQUEST) - BUT BEFORE THE TWO HOURS OF CLAMPING - PATIENT'S INTRAVENTRICULAR PRESSURE INCREASED. NURSE DOUBTS WHETHER TO RECORD (TAKE INTO ACCOUNT) THE IVP VALUE, AS IT IS POTENTIALLY UNRELIABLE DUE TO THE INTRODUCTION OF ACTILYSIS - PHYSICIAN CAME TO THE ROOM AND WAS CONCERNED OF THE NUMBER, SO THE ZERO OF THE EVD WAS CARRIED OUT BY NURSE TWICE ==> IVP AT 6 ==> SO LESS STRESS FOR NURSE AND PHYSICIAN BUT AS THE EVD HAS NOT PRESENTED A ¿BEAUTIFUL¿ TRACE AND THEREFORE WAS NOT VERY RELIABLE. NURSE AND PHYSICIAN WARNED SINCE THE FIRST EVD OBSTRUCTIONS). AROUND 7 P.M.-8 P.M. AND 9 P.M.: LOWER INTERMEDIATE AND UNREACTIVE PUPILS THEN AROUND 10-11 P.M. (10:45 P.M. PRECISELY ON SECOND CHECK OF THE PUPILS ON THE UNRELIABILITY OF THE EQUIPMENT: DVE): UPPER INTERMEDIATE PUPILS SEE MYDRIASIS AND UNRE

  Patient problems: Insufficient Information

  MAUDE report 21095539 ↗
• InjuryMay 9, 2024Leak/Splash; Leak/Splash

  A FACILITY REPORTED A CSF DRAIN SYSTEM (EDS3 ID (B)(4) WITHOUT VENTRICULAR CATHETER) WAS CONNECTED TO AN EXTERNAL VENTRICULAR DERIVATION. ON (B)(6) 2024, THE DOCTOR NOTICED A LEAK ON THE PROXIMAL STOPCOCK: IT WAS PERFORATED. ALL THE SYSTEM WAS REPLACED AT BEDSIDE, NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282318 ↗
• InjuryMar 24, 2024Leak/Splash; Leak/Splash

  A FACILITY REPORTED A LEAK WAS NOTICED ON EDS3 DRAINAGE SYSTEM (ID 821730C) AT THE LEVEL OF VALVE (SAMPLING TAP) DURING THE CHANGE OF BANDAGE. THE DRAINAGE SYSTEM WAS IMPLANTED ON (B)(6) 2024 DUE AN ARTERIOVENOUS MALFORMATION. THE ANTI-REFLUX VALVE WAS REPLACED, THEN THE ENTIRE SYSTEM WAS REPLACED AS IT WAS STILL LEAKING.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18966526 ↗
• MalfunctionMar 29, 2022Break; Break

  A PHYSICIAN REPORTED THAT AS THE PATIENT WAS TRYING TO REMOVE THE CATHETER ON HIS OWN, SURGEON REMOVED THE DEVICE BUT THE WHITE TIP DETACHED FROM THE CATHETER. IT HAPPENED AT THE LEVEL OF SKIN AND NOT INSIDE THE VENTRICLE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13941929 ↗