CODMAN® 821731CRecalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® EDS 3™ CSF External Drainage System · Class 2
All models of CODMAN (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10381780518327), received between Sep 6, 2023 and Jan 24, 2025 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash4
- Fluid/Blood Leak3
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Contaminated During Manufacture or Shipping1
- Fracture1
- Misconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information3
- High Blood Pressure/ Hypertension1
- Nausea1
- Tachycardia1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionNov 22, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
A FACILITY REPORTED A HAIR WAS FOUND IN AN UNOPENED STERILE PACKAGING OF AN EXTERNAL DRAINAGE SYSTEM (ID 821731C). NO PATIENT CONTACT/INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20757300 ↗MalfunctionAug 28, 2024Fracture; Fracture
MalfunctionAug 27, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
MalfunctionJul 26, 2024Leak/Splash; Leak/Splash
A FACILITY REPORTED AN EXTERNAL DRAINAGE SYSTEM (ID 821731C) WAS LEAKING AT THE LEUR LOCK CONNECTION AND LEAK DID NOT STOP AFTER CONNECTION WAS TIGHTENED. THEREFORE, AN EVD TUBE WAS REPLACED. NO SERIOUS HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19838980 ↗MalfunctionJul 12, 2024Leak/Splash; Leak/Splash
A FACILITY REPORTED AN EXTERNAL DRAINAGE SYSTEM (ID 821731C) WAS LEAKING FROM THE BURETROL WHILE BEING USED ON A PATIENT. NO PATIENT INJURY REPORTED, AND THE EVENT DID NOT LEAD TO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19731509 ↗MalfunctionMay 29, 2024Misconnection; Misconnection
A FACILITY REPORTED THAT CHANGING THE COLLECTION BAGS OF AN EXTERNAL DRAINAGE SYSTEM (EDS) (ID 821731C) CAUSED DAMAGE OR THE INABILITY TO USE THE CURRENT CONNECTIONS. ON (B)(6) 2024, VENTRICULAR DRAINAGE OF CEREBROSPINAL FLUID (CSF) WAS PERFORMED USING THE EDS. THE PATIENT WAS TAKEN TO THE OPERATIVE ROOM TO REPLACE THE EDS. THE EVENT HAPPENED 4 TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19415007 ↗MalfunctionMay 17, 2024Leak/Splash; Leak/Splash
A FACILITY REPORTED LEAK AT THE PROXIMAL STOPCOCK OF A EDS DRAINAGE SYSTEM AFTER 7 DAYS OF USE, THEREFORE, THE ENTIRE SYSTEM WAS REPLACED. ACCORDING TO CUSTOMER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19346833 ↗MalfunctionNov 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A EDS EXTERNAL DRAINAGE SYSTEM IS LEAKING FROM THE THREE WAY STOCKCOCK. DRAINAGE SYSTEM WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 18221414 ↗MalfunctionSep 20, 2023Leak/Splash; Leak/Splash
InjurySep 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPORTED AN ACCIDENTAL INJECTION OF RADIO CONTRAST MEDIUM INTO THE SAMPLING/INJECTION SITE OF THE VENTRICULAR SHUNT DEVICE IN PLACE OF THE VASCULAR ACCESS. THE CONTRAST PRODUCT WAS THEREFORE INJECTED INTO THE CEREBRAL VENTRICLES. PATIENT PRESENTED WITH NAUSEA, HYPERTENSION, TACHYCARDIA. THE PATIENT IS AN ADULT OF APPROXIMATELY 60 YEARS-OLD. THE FOLLOWING DAYS : GENERAL TONICO-CLONIC CRISIS AND HYDROCEPHALUS MENINGITIS AT PSEUDOMONAS & CANDIDA, SEPTIC VASCULITIS, ISCHEMIC STROKE + APPEARANCE OF STENOSIS. LONG TERM: COGNITIVE PROBLEMS, LEFT HYPOESTHESIA, TOTAL DEPENDENCE, CONTINENCE AND SWALLOWING PROBLEMS. ACTIONS TAKEN IN THE HEALTHCARE ESTABLISHMENT TO MANAGE THE PATIENT: IMMEDIATE MANAGEMENT BY THE INTENSIVE CARE UNIT TEAM. PATIENT HAS INCAPACITATING SEQUELA.
Patient problems: High Blood Pressure/ Hypertension; Nausea; Tachycardia
MAUDE report 17694985 ↗
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- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
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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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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