CODMAN® 823045Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10381780518839), received between Sep 12, 2023 and Feb 6, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 24278013 ↗
• InjuryDec 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  NA.

  Patient problems: Insufficient Information

  MAUDE report 23892412 ↗
• InjuryNov 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 23617423 ↗
• InjurySep 26, 2025Leak/Splash; Leak/Splash

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23154495 ↗
• InjuryFeb 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED A PERITONEAL CATHETER (ID 823045) WAS IMPLANTED ON (B)(6) 2025. A LEAK WAS OBSERVED FROM THE CATHETER THREE DAYS AFTER IMPLANTATION. A RE-OPERATION WAS PERFORMED; ONLY THE PART THAT WAS LEAKED WAS CUT AND A CONNECTOR WAS USED TO FIX IT. THE DOCTOR ASSUMED THAT THE STAPLER MAY HAVE DAMAGED THE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 21432802 ↗
• InjuryFeb 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 21384768 ↗
• InjuryNov 15, 2024Migration; Migration

  A PHYSICIAN REPORTED A PERITONEAL CATHETER (ID 823045) WAS IMPLANTED DUE TO SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) VIA VENTRICULOPERITONEAL (VP) SHUNT ON SEPTEMBER 23, 2022, WITH SETTING 1. THE PATIENT HAD DEVELOPED VENTRICULAR DILATATION. THE PERITONEAL CATHETER RUPTURED IN THE CONNECTING PART OF THE VALVE, AND IT WAS NOT LIGATED. THE CATHETER HAD FALLEN OF IN THE ABDOMEN. DUE TO THE ISSUE, THE CATHETER WAS REMOVED AND REPLACED ON (B)(6) 2024. THE PATIENT RECOVERED. THE PATIENT PRIMARY DISEASE IS SUBARACHNOID HEMORRHAGE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY ADDITIONAL SIGNS AND SYMPTOMS.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 20694728 ↗
• InjuryJun 8, 2024Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED A HAKIM PERITONEAL CATHETER (ID 823045) WAS IMPLANTED DUE TO IDIOPATHIC NORMAL-PRESSURE HYDROCEPHALUS (INPH) VIA LUMBOPERITONEAL (LP) SHUNT ON (B)(6) 2023 WITH SETTING 5. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ) AND CERTAS PLUS VALVE (ID 828804). THE DOCTOR SUSPECTED THAT THE VALVE HAD FLIPPED, SO THEY ADMINISTERED A LOCAL ANESTHESIA AND FIXED THE VALVE IN ITS ORIGINAL POSITION. DURING THE PROCEDURE, THEY TRIED TO PUMP, BUT THE RESERVOIR REMAINED UNCHANGED. DUE TO SUSPICION OF OBSTRUCTION, PERITONEAL CATHETER, SILASCON AND CERTAS VALVE WERE REMOVED ON (B)(6) 2024. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS OR SYMPTOMS DUE TO THE REPORTED ISSUE. IT IS NOT KNOWN WHEN THE NEW DEVICE WILL BE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 19494575 ↗
• InjuryJun 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED A PERITONEAL CATHETER (B)(6) WAS IMPLANTED VIA LUMBOPERITONEAL (L-P) SHUNT DUE TO VENTRICULAR DILATATION 6 MONTHS AGO. ON AN UNKNOWN DATE, A LEAK AND INFECTION WERE NOTED. THE CAUSE OF INFECTION WAS DUE TO A LEAKAGE FROM THE PART WHERE A LUMBAR PUNCTURE WAS PERFORMED. THE CATHETER WAS USED ALONG WITH THE CERTAS VALVE (B)(6) PRODUCTS WERE REMOVED AND REPLACED BY AN EXTERNAL VENTRICULAR DRAINAGE SYSTEM. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN WHICH DEVICE WAS REMOVED, IT IS ALSO UNKNOWN THE TYPE OF INFECTION/ORGANISM AND THE TESTS USED TO CONFIRM IT. THE TREATMENT OR MEDICATION USED TO TREAT THE INFECTION IS UNKNOWN. PRIMARY DISEASE: SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH).

  Patient problems: Cerebral Ventriculomegaly; Cerebrospinal Fluid Leakage; Unspecified Infection

  MAUDE report 19466934 ↗
• InjuryApr 12, 2024Obstruction of Flow; Obstruction of Flow

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3013886523-2024-00115: A FACILITY REPORTED THAT THE HAKIM PERITONEAL CATHETER (823045) WAS EXPLANTED DUE TO SUSPICION OF OBSTRUCTION. THE PRESSURE SETTING ON THE VALVE WAS CHANGEABLE. THE IMPLANT AND EXPLANT DATES ARE UNKNOWN, AND PATIENT INFORMATION IS ALSO UNKNOWN. THERE WAS NO SURGICAL DELAY. REOPERATION WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Insufficient Information

  MAUDE report 19101919 ↗
• InjuryNov 22, 2023Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 18192182 ↗
• InjurySep 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00314 A PHYSICIAN REPORTED A CERTAS VALVE (828804) WAS IMPLANTED VIA LUMBAR PERITONEAL (LP) SHUNT ON (B)(6) 2022 WITH SETTING 2. THE VALVE WAS USED WITH THE SILASCON® LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ), AND PERITONEAL CATHETER (823045) WITH UNKNOWN SERIAL NUMBER. ON (B)(6) 2022, THE PATIENT'S SYMPTOMS WORSENED. AN ENLARGEMENT OF THE VENTRICLES AND SUBCUTANEOUS CEREBROSPINAL FLUID RETENTION WERE CONFIRMED. THE PATIENT WAS DIAGNOSED WITH MENINGITIS. THE SETTING WAS CHANGED FROM 2 TO 1, HOWEVER THE PATIENT'S HYDROCEPHALUS DID NOT IMPROVE. ON (B)(6) 2023, THE SHUNT SYSTEM WAS REMOVED. WHEN THE CATHETER WAS REMOVED FROM THE ABDOMINAL CAVITY WITH THE VALVE AND LUMBAR CATHETER LEFT IN PLACE, THE RESERVOIR REMAINED DEPRESSED AND DID NOT RETURN DESPITE PUMPING. THERE WERE NO OBSTRUCTIONS OF THE LUMBAR CATHETER AND ABDOMINAL CATHETER. THE PATIENT IS CURRENTLY UNDER OBSERVATION WITH VENTRICULAR DRAINAGE. THE VALVE WAS REMOVED ON (B)(6) 2023 AND WAS NOT REPLACED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THERE IS AN OBSTRUCTION WITH THE VALVE. IT IS ALSO UNKNOWN IF THE INFECTION IS RELATE

  Patient problems: Meningitis

  MAUDE report 17741050 ↗
• InjurySep 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00305. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) AND A HAKIM PERITONEAL CATHETER (ID 823045) WERE IMPLANTED VIA LUMBAR PERITONEAL SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. ON (B)(6) 2023, GAIT DISORDER WAS OBSERVED AND OBSTRUCTION WAS SUSPECTED. THE VALVE AND HAKIM CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2023. THE PATIENT RECOVERED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE HAKIM CATHETER FAILED, HOWEVER IT WAS EXPLANTED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 17729557 ↗