CODMAN CERTAS 82-8810PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704081890), received between Dec 30, 2021 and Aug 20, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (2 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryDec 30, 2021Output Problem; Output Problem

  N/A

  Patient problems: Insufficient Information

  MAUDE report 13117043 ↗