CODMAN® 823041Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® Ventricular Catheter Straight · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780518815), received between Aug 22, 2023 and Oct 17, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Obstruction of Flow” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Cerebral Ventriculomegaly2
- Insufficient Information2
- Cerebral Edema1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2025Obstruction of Flow; Obstruction of Flow
InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2024-00267 A PHYSICIAN REPORTED A VENTRICULAR CATHETER (ID 823041) AND A PERITONEAL CATHETER (ID 823045) WERE IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE CATHETERS WERE USED TOGETHER WITH A CERTAS PLUS VALVE (ID 828804). ALL THREE DEVICES WERE REMOVED ON AN UNKNOWN DATE DUE TO THE VALVE NOT FUNCTIONING PROPERLY AFTER IMPLANTATION. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THERE WAS AN ISSUE WITH THE CATHETERS, HOWEVER, THEY WERE EXPLANTED. IT IS ALSO UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS OR SYMPTOMS DUE TO VALVE FAILURE. THE PATIENT'S CONDITION IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20150751 ↗InjuryAug 23, 2024Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A VENTRICULAR CATHETER (ID 823041) AND A CERTAS VALVE WERE IMPLANTED WITH UNKNOWN SETTING DUE TO HYDROCEPHALUS. SUBCUTANEOUS CSF ACCUMULATION WAS OBSERVED AROUND THE DEVICE. THE VALVE'S PATENCY WAS CONFIRMED THROUGH RADIO ISOTOPES. THEREFORE, THE VALVE AND THE CATHETER WERE REMOVED AND REPLACED. WHEN IMPLANTING THE NEW VENTRICULAR CATHETER, THE INSERTION LOCATION WAS CHANGED FROM FRAZIER¿S POINT TO KOCCHER¿S POINT. IT WAS STATED THAT, THE SURGEON COULD NOT THINK OF THE CAUSATION OF SUBCUTANEOUS RETENTION OTHER THAN THE VALVE BREAKAGE. IT WAS CONFIRMED THAT THE VALVE WAS NOT BROKEN, HOWEVER, THERE WAS A SUSPICION OF VENTRICULAR CATHETER BLOCKAGE. THE PATIENT IS CURRENTLY IN FOLLOW UP. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO SUSPECTED CATHETER BLOCKAGE.
Patient problems: Cerebral Edema
MAUDE report 20051374 ↗InjuryFeb 27, 2024Obstruction of Flow; Obstruction of Flow
InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00280. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814) AND HAKIM VENTRICULAR CATHETER (ID 823041) WERE IMPLANTED VIA VENTRICULAR PERITONEAL SHUNT ON (B)(6), 2023 WITH SETTING 3. THE PATIENT VISITED THE HOSPITAL ON (B)(6) WITH RECURRENCE OF SYMPTOMS. ON (B)(6) 2023, VENTRICULAR ENLARGEMENT WAS CONFIRMED BY X-RAY EXAMINATION. THE CHAMBER COULD NOT BE PUSHED, AND THE FLOW HAD STOPPED. DUE TO SUSPICION OF OBSTRUCTION, THE VALVE AND CATHETER WERE REMOVED AND REPLACED ON (B)(6), 2023.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 17596608 ↗
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- 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
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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 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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