CODMAN CERTASRecalls & reported problems across all models

We found 5 models of CODMAN CERTAS by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2018 and Oct 10, 2025 — classified as 1 death, 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Output Problem” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CODMAN CERTAS problems

CODMAN CERTAS models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CODMAN CERTAS 82-8800PL

  Shunt, central nervous system and components
  1 death7 reports
• CODMAN CERTAS 82-8810PL

  Shunt, central nervous system and components
  6 reports
• CODMAN CERTAS 82-8851

  Shunt, central nervous system and components
  4 reports
• CODMAN CERTAS 82-8811PL

  Shunt, central nervous system and components
  2 reports
• CODMAN CERTAS 82-8802PL

  Shunt, central nervous system and components
  1 report

Recent CODMAN CERTAS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2025Failure to Align; Failure to Align

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23266826 ↗
• InjuryAug 20, 2024Positioning Failure; Positioning Failure

  MEDWATCH #: (B)(4). A FACILITY REPORTED A CERTAS VALVE (ID 828810PL) WAS IMPLANTED ON (B)(6) 2021 WITH SETTING AT 3. IN (B)(6) 2023, THE VALVE WAS REPROGRAMMED FROM 3 TO 5 DUE TO A PROGRESSIVE DECREASE IN VENTRICLE SIZE. THE PATIENT DID WELL WITH NO RECURRENT SEIZURES. ON (B)(6) 2024, DURING A CLINIC VISIT, IT WAS FOUND THAT THE VALVE COULD NO LONGER BE ADJUSTED FROM ITS SETTING OF 3 AND THE MAGNETIC RESONANCE IMAGING (MRI) SHOWED DILATATION OF THE LEFT LATERAL VENTRICLE, WHICH WAS HIGHER THAN WHAT WAS SEEN ON IMAGING IN (B)(6) 2023. THE VENTRICLE SIZE IN (B)(6) 2024 WAS LARGER THAN HER PREVIOUS VENTRICLES SIZE WHEN HER PREVIOUS INTENTIONAL SETTING WAS AT 3 IN (B)(6) OF 2023. BETWEEN (B)(6) 2024 AND (B)(6) 2024, THE PATIENT HAD WORSENING OF ABILITY TO PERFORM MOTOR SKILLS (STOPPED WALKING IN (B)(6) 2024), RUBBING EARS AND RUBBING HEAD (NON-VERBAL PATIENT), WAKING FROM SLEEP CRYING, INABILITY TO SLEEP IN RECUMBENT, INCREASED DAYTIME IRRITABILITY, AND PROGRESSIVE VENTRICULAR DILATION DUE TO ABNORMAL INTRACRANIAL PRESSURE. THE VALVE WAS REMOVED AND REPLACED. THE PATIENT SYMPTOMS IMPROVED, IS NOW WALKING AGAIN AND NO LONGER RUBBING EARS OR HEAD.

  Patient problems: Ambulation or Postural Difficulties; Cerebral Ventriculomegaly; Irritability

  MAUDE report 20004135 ↗
• InjuryFeb 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Dizziness

  MAUDE report 18787811 ↗
• InjuryJun 9, 2023Obstruction of Flow; Obstruction of Flow

  A FACILITY REPORTED A CERTAS VALVE (ID 828810PL) WAS IMPLANTED ON (B)(6) 2021 WITH SETTING 7 OF 38MMH20. DURING A CLINIC CHECK UP THE VALVE WAS FOUND TO BE "STUCK". THERE WERE SEVERAL ATTEMPTS TO CHANGE/UNSTICK THE VALVE TO THE DESIRED SETTING. ON (B)(6) 2023 , THE DECISION WAS MADE TO EXPLANT THE VALVE AND TEST THE COMPONENTS TO FIND THE CAUSE OF THE ISSUES. VENTRICULAR CATHETER WAS CHECKED AND WAS CONFIRMED OPERATIONAL WITH AN ICP OF 16 BASED ON MANOMETER READING. PERITONEAL CATHETER WAS CHECKED AND CONFIRMED OPERATIONAL FROM MANOMETER. THE VALVE WAS EXPLANTED TESTED AT 110 MMH2O. A NEW VALVE WAS IMPLANTED AT SETTING 4 = 110 MMH2O.

  Patient problems: Insufficient Information

  MAUDE report 17100880 ↗
• MalfunctionJan 13, 2023Inappropriate or Unexpected Reset

  PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REVISION OF VENTRICULAR SHUNT. A PRE MRI SHUNT DIAL XRAY WAS PERFORMED AND SETTING NOTED AT 4. POST MRI SHUNT DIAL X-RAY NOTED A CHANGE IN SETTING TO 6. NEUROSURGERY UNABLE TO ADJUST VALVE. CODMAN COMPANY REP PRESENT AND UNABLE TO ADJUST VALVE. SHUNT HAD TO BE SURGICALLY REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16156729 ↗
• InjuryDec 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERTAS VALVE (ID 828811PL) WAS IMPLANTED ON (B)(6) 2022 WITH A SET PRESSURE OF 7. ON (B)(6) 2022, VALVE WAS FOUND TO BE INCORRECTLY SET TO 3. THE PATIENT HAD SYMPTOMS OF OVER-DRAINAGE. A 3T MRI WAS PERFORMED ON (B)(6) 2022 PRIOR ON FINDING THE INCORRECT SETTING. THE VALVE WAS REMOVED ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 16064203 ↗
• MalfunctionSep 14, 2022Pressure Problem; Pressure Problem

  A FACILITY REPORTED A CERTAS VALVE (ID 828810PL) WAS IMPLANTED IN A 17 YEAR OLD MALE PATIENT ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT HAD AN MRI. IMMEDIATELY FOLLOWING THE MRI THE VALVE WAS CHECKED WITH THE CERTAS MANUAL VERIFICATION TOOL. IT WAS VERIFIED THAT THE VALVE WAS SET TO SETTINGS 6. THE PATIENT WAS THEN SENT TO X-RAY TO CONFIRM AND IT WAS CONFIRMED THAT THE VALVE WAS AT SETTING 6. THEN THEY REPROGRAMMED THE PATIENT BACK TO SETTING 5 AND WAS CONFIRMED WITH THE MANUAL VERIFICATION TOOL AND X-RAY. IT WAS STATED THAT THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS OF UNDER DRAINAGE BECAUSE OF THE HIGHER SETTING. THE VALVE REMAINS IMPLANTED AT THE TIME OF THIS REPORT. THE PATIENT IS DOING FINE WITH CERTAS PLUS VALVE CURRENTLY SET TO SETTING 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420403 ↗
• InjuryAug 24, 2022Output Problem; Output Problem

  A FACILITY REPORTED A CERTAS VALVE (ID 828800PL) WAS IMPLANTED ON (B)(6), 2019. ON (B)(6), 2022 THE PATIENT ATTEMPTED TO HAVE SHUNT REPROGRAMMED FROM A SETTING 5 TO 6. THEY ATTEMPTED TO REPROGRAM TO 6 AND BOTH THE MANUAL AND ELECTRONIC PROGRAM CONFIRMED CHANGE. THE PATIENT WAS SENT DOWN TO X-RAY TO CONFIRM BUT X RAY CONTINUED TO SHOW VALVE WAS AT A 5. THEY SET SHUNT AT 7 AS THAT WAS CLOSEST TO 6 BUT ON AUGUST 05, 2022, PATIENT PRESENTED WITH SHUNT FAILURE SYMPTOMS, THEREFORE, THE VALVE WAS EXPLANTED AND REPLACED WITH A NEW VALVE. THE PATIENT WAS HAVING SIGNS OF VENTRICULAR ENLARGEMENT AND SEVERE LETHARGY WHEN UNDERDRAINING.

  Patient problems: Cerebral Ventriculomegaly; Lethargy

  MAUDE report 15284170 ↗
• MalfunctionAug 10, 2022Defective Component; Defective Component

  A FACILITY REPORTED THAT THE PRESSER CHECKING TOOL OF A CERTAS TOOL KIT (ID: 828851) DOES NOT WORK. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199750 ↗
• InjuryMay 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED A CERTAS VALVE (ID 828800PL) WAS IMPLANTED VIA L-P SHUNT ON (B)(6) 2022. A POCKET OF FLUID AROUND THE SHUNT VALVE WAS FOUND AND THE GRAVITY COMPENSATOR WAS LEAKING, THEREFORE THE VALVE WAS REMOVED ON (B)(6) 2022. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO THE VALVE ISSUE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 14477792 ↗
• MalfunctionApr 6, 2022No Device Output; No Device Output

  A FACILITY REPORTED THE CERTAS TOOL KIT WAS NOT ABLE TO ADJUST THE VALVE SETTING. NO PATIENT INJURY OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021547 ↗
• MalfunctionMar 29, 2022No Device Output; No Device Output

  A FACILITY REPORTED IT WAS NOT POSSIBLE TO ADJUST THE SETTINGS OF A VALVE WITH THE CERTAS TOOL KIT. A REPLACEMENT PRODUCT WAS USED TO ADJUST THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943452 ↗
• InjuryMar 29, 2022Pressure Problem; Pressure Problem

  A FACILITY REPORTED A CERTAS VALVE WAS IMPLANTED WITH SETTING 5 ON (B)(6) 2020 TO TREAT HYDROCEPHALUS. DUE TO SOME BLOOD IN THE VENTRICLES, THE SETTING WAS CHANGED TO 7 ON THE SAME DAY. ON (B)(6) 2020, THE SETTING WAS CHANGED TO 5 WITH DIGITAL AND MAGNETIC CONFIRMATION. IN (B)(6) 2022, THE PATIENT'S PARENTS CALLED INFORMING THE PATIENT HAD IRRITABILITY WHICH PROGRESSED INTO VOMITING AND IT WAS FOUND THE VALVE WAS SET AT SETTING 8 (SUPPOSED TO BE IN 5). IT IS UNKNOWN IF THE PATIENT HAD MAGNETIC EXPOSURE, MRIS, ETC. THE VALVE WAS ADJUSTED TO SETTING 5, CONFIRMED ON THE MACHINE AND X-RAY. PATIENT IMPROVED.

  Patient problems: Irritability; Vomiting

  MAUDE report 13938519 ↗
• InjuryMar 1, 2022Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED A CERTAS VALVE (ID 828800) WAS IMPLANTED IN A (B)(6) FEMALE PATIENT VIA "L-P" SHUNT ON (B)(6) 2021 WITH SETTING 2. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). A SHUNT DYSFUNCTION WAS SUSPECTED AND SHUNT CONTRAST EXAMINATION CONFIRMED A PROXIMAL OBSTRUCTION ON (B)(6) 2022. THE PATIENT HAD REPEATED FALLS AND IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS. THE VALVE AND THE LUMBAR CATHETER WERE REMOVED ON (B)(6) . THE VALVE WAS REPLACED ON (B)(6) . THE PATIENT RECOVERED.

  Patient problems: Balance Problems

  MAUDE report 13636305 ↗
• DeathFeb 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A VALVE (UNKNOWN MANUFACTURER) HAS BEEN IMPLANTED FOR 40 YEARS AND NEVER REVISED. THE PATIENT IS A (B)(6) FEMALE SINCE BIRTH PRESENTED WITH PROXIMAL VP SHUNT OBSTRUCTION. THE PATIENT PRESENTED WITH HYDROCEPHALUS AND HEADACHES FOR 72 MONTHS AND ON (B)(6) 2022, A CERTAS PLUS VALVE (ID (B)(6)) WAS IMPLANTED WITH SETTING 5. AT THE TIME OF THE VALVE IMPLANTATION, THE PATIENT HAD A HEADACHE, BUT SHE WAS NEUROLOGICALLY INTACT AND THERE WERE NO ISSUES DURING VALVE INSERTION. THE PATIENT WAS MONITORED IN ICU FOR 24 HOURS AND ON (B)(6) 2022, THE SHUNT SETTINGS CHANGED FROM 5 TO 3 AND THE PATIENT CODED (TACHYCARDIC AND WAS FOUND UNRESPONSIVE IN BED). THE PATIENT SUFFERED CARDIAC ARREST AT APPROXIMATELY 9:00P.M. ON (B)(6) 2022, A REVISION SURGERY WAS ATTEMPTED UNSUCCESSFULLY DUE TO COLLAPSED VENTRICLES DUE TO MASSIVE BRAIN EDEMA. THE PATIENT PASSED AWAY ON (B)(6) 2022.

  Patient problems: Cerebral Edema; Headache; Hydrocephalus

  MAUDE report 13506957 ↗

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