CODMAN CERTAS® Plus 828814PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10381780529378), received between Jan 11, 2022 and Feb 27, 2026 — classified as 19 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERTAS VALVE (ID (B)(6)) WAS IMPLANTED ON (B)(6) AND THEN REMOVED AND REPLACED DUE TO AN INCREASE IN INTRACRANIAL PRESSURE (ICP). AS PER REPORTER, THE PATIENT EXPERIENCED SIGNS AND SYMPTOMS OF INCREASED ICP, HOWEVER, DETAILS WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24469894 ↗
• InjuryDec 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23892443 ↗
• MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A FACILITY REPORTED THE SIPHONGUARD OF A CERTAS VALVE (ID 828814PL) DETACHED/FRACTURED AFTER IMPLANTATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AFTER SEVERAL ATTEMPTS.

  Patient problems: Insufficient Information

  MAUDE report 23832417 ↗
• InjuryAug 14, 2025Leak/Splash; Leak/Splash

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 22809213 ↗
• InjuryMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  3 OF 3 REPORTS (SAME PRODUCT FAILURE, DIFFERENT PATIENTS). OTHER MFG REPORT NUMBERS: 3013886523-2025-00100, 3013886523-2025-00097. A FACILITY REPORTED A CERTAS VALVE (ID 828804PL) WAS IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, AN MRI REVEALED THAT THE SIPHONGUARD HAD COMPLETELY DETACHED FROM BODY OF VALVE, REQUIRING REVISION SURGERY FOR EXPLANTATION AND REPLACEMENT. THE PATIENT PRESENTED WITH CSF LEAK DUE TO VALVE FAILURE. CURRENT STATUS OF THE PATIENT - NO LONG-TERM DAMAGE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 22010267 ↗
• InjuryMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  1 OF 3 REPORTS (SAME PRODUCT FAILURE, DIFFERENT PATIENTS). OTHER MFG REPORT NUMBERS: 3013886523-2025-00097 3013886523-2025-00098. A PHYSICIAN REPORTED A CERTAS VALVE (828814PL) WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2023, A MAGNETIC RESONANCE IMAGING (MRI) REVEALED THAT THE SIPHON GUARD WAS DETACHED FROM THE BODY OF THE VALVE, REQUIRING REVISION SURGERY FOR EXPLANTATION AND REPLACEMENT. THE PATIENT EXPERIENCED HEADACHE DUE TO VALVE FAILURE. CURRENT STATUS OF THE PATIENT - NO LONG TERM DAMAGE

  Patient problems: Headache

  MAUDE report 22009657 ↗
• InjuryNov 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PHYSICIAN REPORTED A CERTAS VALVE (UNKNOWN ID) WAS IMPLANTED ON (B)(6) 2024, IN A 3-YEAR-OLD FEMALE PATIENT. THE PATIENT SLIPPED AND HIT THE HEAD ON THE HARDWOOD FLOOR CLOSED TO THE IMPLANTED SHUNT. AFTER TWO TO THREE HOURS, SHUNT FAILURE SYMPTOMS WERE NOTICED SUCH AS LETHARGY AND VOMITING. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024. THERE WERE NO VISIBLE CRACKS OR BLOCKAGE NOTICED HOWEVER, THERE WAS A BLOOD IN THE SIPHONGUARD.

  Patient problems: Lethargy; Vomiting

  MAUDE report 20757299 ↗
• InjurySep 5, 2024Improper Flow or Infusion; Improper Flow or Infusion

  A FACILITY REPORTED AN IMPROPER FLOW THROUGH THE CERTAS VALVE (ID 828814PL) DURING REVISION SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS

  Patient problems: Insufficient Information

  MAUDE report 20150869 ↗
• InjuryAug 20, 2024No Flow; No Flow

  A FACILITY REPORTED NO FLOW OF A CERTAS VALVE (ID 828814PL) THAT WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE VALVE WAS ADJUSTED FROM 4 TO 2 DUE TO IMAGING FINDINGS (INTERVAL DILATION OF THE RIGHT VENTRICLE) AND THE PATIENT TOLERATED THE ADJUSTMENT WITH IMPROVED SYMPTOMS OVERNIGHT. ON (B)(6) 2024, THE PATIENT EXPERIENCED VOMITING, INCREASED IRRITABILITY, APPETITE CHANGE, CRYING, ABDOMINAL PAIN, AND INCREASED SLEEPING. IMAGING REPEATED SHOWING INCREASE IN VENTRICLE. AT THIS TIME, THE VALVE WAS RE-PROGRAMMED FROM 2 TO 1. ON (B)(6) 2024, THE PATIENT SHOWED NO IMPROVEMENT OF SYMPTOMS AND THE IMAGING SHOWED NO CHANGE TO VENTRICULAR CALIBER DESPITE THE REPROGRAMMING THAT OCCURRED THE PREVIOUS DAY FROM 2 TO 1. THEREFORE, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REVISION, AND THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2024. THERE IS NO OTHER DEVICE OR THERAPY BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IT IS ALSO UNKNOWN IF THE PATIENT HAD ANY OF THE PRE-EXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT. PATIENT RETURNED TO ITS NEUROLOGIC BASELINE.

  Patient problems: Abdominal Pain; Sleep Dysfunction; Vomiting

  MAUDE report 20004193 ↗
• InjuryAug 9, 2024Infusion or Flow Problem; Infusion or Flow Problem

  A FACILITY REPORTED IMPROPER FLOW OF A CERTAS VALVE (ID 828814PL). THE ISSUE WAS FOUND DURING REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950114 ↗
• InjuryJun 7, 2024Break; Break

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00163. A FACILITY REPORTED A PATIENT WHO EXPERIENCED A FALL AT HOME. THE PATIENT HAD BEEN USING A CERTAS VALVE (ID (B)(6)) BEFORE THE FALL. THE VALVE MALFUNCTIONED AND RESULTED IN REVISION SURGERY ON (B)(6) 2024. IT WAS REMOVED AND REPLACED WITH THE CERTAS VALVE (ID (B)(6)). ON (B)(6) 2024, THE PATIENT WAS DISCHARGED. ON (B)(6) 2024, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO A FLUID ACCUMULATION UNDER THE INCISION AROUND THE VALVE. THE CUSTOMER DESCRIBED AS IT HAD SNAPPED. A REVISION SURGERY WAS PERFORMED ON THE SAME DAY, AND IT WAS FOUND THAT THE SHUNT WAS BROKEN. THE VALVE WAS REMOVED ALONG WITH ALL ITS BROKEN PARTS. AFTER REPLACING THE VALVE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO VERIFY THAT THE NEW ONE WAS IN PLACE AND OPERATING PROPERLY. WITH NO CONCERNS, THE PATIENT IS NOW AT HOME AND IS IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 19487678 ↗
• InjuryJan 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 18584006 ↗
• InjuryNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) WAS EXPLANTED AS IT WAS NOT FUNCTIONING PROPERLY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: Insufficient Information

  MAUDE report 18232104 ↗
• InjuryNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) WAS NOT WORKING PROPERLY AFTER INSERTION. IT WAS DEFECTIVE AND NOT PERFORMING TO THE NORMAL STANDARDS THEREFORE, IT REQUIRED REMOVAL AND REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18231818 ↗
• InjuryAug 8, 2023Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED 3.5 YEARS AGO WITH SETTING 5. USING THE ELECTRONIC TOOL KIT (ETK), MEDICAL STAFF TRIED TO REPROGRAM SHUNT TO SETTING 7, HOWEVER, THE VALVE STAYED AT 5. AFTER MANY ATTEMPTS INCLUDING WITH MULTIPLE ETK KITS AND MAGNETS, THE SETTING REMAINED AT 5. THE LARGE MAGNET COULD NOT MOVE THE SETTING OFF OF 5. THE PATIENT DID NOT EXPERIENCED ANY SIGNS AND SYMPTOMS OF VALVE MALFUNCTION AND PHYSICIAN ONLY WANTED TO PROGRAM SETTING 7 AS THE PATIENT HAD A SUBDURAL DUE TO A FALL (THE PATIENT FELL OUT OF BED A FEW WEEKS AGO POSSIBLY DAMAGING THE VALVE). THE VALVE WAS REPLACED ON (B)(6), 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480505 ↗
• MalfunctionMay 26, 2023Infusion or Flow Problem; Infusion or Flow Problem

  A FACILITY REPORTED A CERTAS VALVE (ID 828814PL ) WAS NOT FLOWING PROPERLY: "DURING SURGERY THE CERTAS VALVE W/SIPHONGUARD AND SHUNT WERE IMPLANTED BUT THERE WAS NO DISTAL FLOW FROM THE PERITONEAL CATHETER. THE VENTRICULAR CATHETER WAS THEN DISCONNECTED TO MAKE SURE IT WAS PATIENT AND CSF FLOW WAS CONFIRMED. THE VALVE WAS INSPECTED, FLUSHED AGAIN AS WAS THE PERITONEAL CATHETER. IT WAS RECONNECTED AND AGAIN NO DISTAL FLOW. THE VALVE WAS THEN REPLACED WHEN A NEW CERTAS VALVE WITH SIPHONGUARD AND GOOD DISTAL FLOW WAS NOTED CONFIRMING THE ORIGINAL VALVE WAS FAULTY.". NO PATIENT INJURY REPORTED, AND THE EVENT LED TO 30 MINUTES SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010618 ↗
• MalfunctionFeb 16, 2023Output Problem; Output Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 16387203 ↗
• MalfunctionFeb 16, 2023Output Problem; Output Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 16387201 ↗
• MalfunctionFeb 16, 2023Output Problem; Output Problem

  3 OF 5 REPORTS (DIFFERENT FACILITIES, SAME FAILURE, SAME PRODUCT FAMILY). OTHER MFG REPORT NUMBERS: 3013886523-2023-00038; 3013886523-2023-00039; 3013886523-2023-00041; 3013886523-2023-00042. IT WAS REPORTED CERTAS VALVES HAD PROGRAMMING DIFFICULTIES. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AFTER SEVERAL ATTEMPTS.

  Patient problems: Insufficient Information

  MAUDE report 16386960 ↗
• InjuryJan 30, 2023No Device Output; No Device Output

  A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED ABOUT 6 MONTHS AGO TO TREAT HYDROCEPHALUS. THE VALVE WON'T REPROGRAM TO DIFFERENT SETTING. SEVERAL ATTEMPTS WERE MADE TO REPROGRAM TO DIFFERENT SETTING WITH MULTIPLE PROGRAMMERS WITH NO SUCCESS. THE PATIENT WAS EXPERIENCING IRRITABILITY AND FATIGUE (ALSO HAD EAR INFECTION. THEREFORE, THE VALVE NEEDED TO BE REVISED.

  Patient problems: Fatigue; Irritability

  MAUDE report 16263955 ↗
• InjuryDec 13, 2022Break; Break

  A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED TO TREAT HYDROCEPHALUS WITH PRESSURE SETTING 1. THE VALVE BROKE ABOUT 1 MONTH AFTER IMPLANTATION DUE TO SIPHONGUARD DISCONNECTION FROM VALVE MECHANISM. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. BASED ON INFORMATION PROVIDED, THERE WAS A FLUID COLLECTION THAT APPEARED UNDERNEATH THE SHUNT INCISION.

  Patient problems: Insufficient Information

  MAUDE report 15971942 ↗
• InjuryMay 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00208, 3013886523-2022-00215 AND 3013886523-2022-00216. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED IN THE RIGHT SIDE OF A (B)(6) PATIENT ON (B)(6) 2022. THE INITIAL SETTINGS WERE FINE WHEN THE PHYSICIAN TOOK OVER THE CARE, HOWEVER, VENTRICLE LATER COLLAPSED. THEN ANOTHER CERTAS VALVE (ID 828814PL) WAS IMPLANTED IN THE LEFT SIDE ON (B)(6) 2022, HOWEVER, THE VALVE WAS NOT PERFORMING AS IT SHOULD. THEREFORE, BOTH VALVES WERE EXPLANTED ON UNKNOWN DATE. ON (B)(6) 2022 TWO ADDITIONAL CERTAS VALVE (ID 828814PL) WERE IMPLANTED WHICH ALSO NOT UP TO PERFORMANCE. BASED ON INFORMATION PROVIDED, THE PATIENT IS NOT DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 14492697 ↗
• MalfunctionMay 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00208. 3013886523-2022-00209. 3013886523-2022-00215. A PHYSICIAN REPORTED A CERTAS VALVE (ID (B)(4)) WAS IMPLANTED IN THE RIGHT SIDE OF A 12-YEAR-OLD PATIENT ON (B)(6) 2022. THE INITIAL SETTINGS WERE FINE WHEN THE PHYSICIAN TOOK OVER THE CARE, HOWEVER, VENTRICLE LATER COLLAPSED. THEN ANOTHER CERTAS VALVE (ID (B)(4)) WAS IMPLANTED IN THE LEFT SIDE ON (B)(6) 2022, HOWEVER, THE VALVE WAS NOT PERFORMING AS IT SHOULD. THEREFORE, BOTH VALVES WERE EXPLANTED ON UNKNOWN DATE. ON (B)(6) 2022 TWO ADDITIONAL CERTAS VALVE (ID (B)(4)) WERE IMPLANTED WHICH ALSO NOT UP TO PERFORMANCE. BASED ON INFORMATION PROVIDED, THE PATIENT IS NOT DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 14492489 ↗
• MalfunctionMay 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 3 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00208, 3013886523-2022-00209 AND 3013886523-2022-00216. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED IN THE RIGHT SIDE OF A (B)(6) PATIENT ON (B)(6) 2022. THE INITIAL SETTINGS WERE FINE WHEN THE PHYSICIAN TOOK OVER THE CARE, HOWEVER, VENTRICLE LATER COLLAPSED. THEN ANOTHER CERTAS VALVE (ID 828814PL) WAS IMPLANTED IN THE LEFT SIDE ON (B)(6) 2022, HOWEVER, THE VALVE WAS NOT PERFORMING AS IT SHOULD. THEREFORE, BOTH VALVES WERE EXPLANTED ON UNKNOWN DATE. ON (B)(6) 2022 TWO ADDITIONAL CERTAS VALVE (ID 828814PL) WERE IMPLANTED WHICH ALSO NOT UP TO PERFORMANCE. BASED ON INFORMATION PROVIDED, THE PATIENT IS NOT DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 14492479 ↗
• InjuryApr 20, 2022Break; Break

  A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED IN A (B)(6) YEAR-OLD MALE PATIENT ON (B)(6) 2021. THE PATIENT HAD DIZZINESS AND IMBALANCE AFTER 10 TO 12 WEEKS OF IMPLANTATION. THE VALVE WAS EXPLANTED ON (B)(6) 2022 AND AN "EVD" WAS PLACED. THE DISTAL END OF THE SHUNT DETACHED OR BROKE. ALL THE BROKEN PARTS WERE RECOVERED AND NO X-RAY WAS REQUIRED TO ASSURE NO PARTS LEFT IN THE PATIENT BECAUSE THE BROKEN VALVE WAS STILL ATTACHED TO THE DISTAL CATHETER. THE PATIENT IS IN OBSERVATION FOR SEVERAL DAYS AND BEING FOLLOWED BY THE NEURO TEAM.

  Patient problems: Balance Problems; Dizziness

  MAUDE report 14160281 ↗