CODMAN CERTAS® Plus 828800PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10381780521013), received between Apr 5, 2023 and Dec 5, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (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, 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Confusion/ Disorientation; Headache; Vomiting

  MAUDE report 23728865 ↗
• InjuryApr 4, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A PHYSICIAN REPORTED A PATIENT HAS A CERTAS VALVE (ID 828804PL) SET AT 7. THE VALVE OVER DRAINS WHEN THE PATIENT IS SITTING UP AND NORMALIZES WHEN LYING DOWN. THE VALVE WAS TESTED WITH A MANOMETER AND APPEARS TO BE DRAINING COMPLETELY. WHEN THE VALVE IS SET TO 8, IT APPEARS TO WORK AND HOLD STEADY. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2025. ACCORDING TO THE INFORMATION RECEIVED, IT IS UNKNOWN IF THE PATIENT HAD ANY SIGNS OR SYMPTOMS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21773370 ↗
• InjuryJan 29, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  SALES REPRESENTATIVE NARRATIVE: "THE PHYSICIAN REMOVED AND REVISED SHUNT ON (B)(6) 2025. HE NOTIFIED ME ON (B)(6) 2025, THAT THE VALVE THAT HE REMOVED WOULD NOT REPROGRAM. HE REPLACED THE VALVE WITH A NEW CERTAS VALVE. A DIFFERENT NEUROSURGEON IMPLANTED THE VALVE A FEW YEARS AGO".

  Patient problems: Insufficient Information

  MAUDE report 21264699 ↗
• InjurySep 20, 2024Infusion or Flow Problem; Infusion or Flow Problem

  A FACILITY REPORTED A CERTAS VALVE (ID 828804PL) WAS NOT DRAINING CEREBROSPINAL FLUID (CSF), ( THE VENTRICLES WERE NOT DRAINING). THEREFORE THE VALVE WAS EXPLANTED AND REPLACED 3 DAYS AFTER IMPLANTATION. NO SURGICAL DELAY AND THE PATIENT IS DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 20274620 ↗
• MalfunctionSep 20, 2024No Flow; No Flow

  A FACILITY REPORTED: "SURGEON CONNECTED CERTAS PLUS IN-LINE WITH MEDTRONIC CSF RESERVOIR. UPON CONNECTING THE SYSTEM WITH VENTRICULAR AND PERITONEAL CATHETERS, THE SURGEON DID NOT EXPERIENCE FLOW. THE CERTAS PLUS WAS SET TO SETTING 4. MULTIPLE ATTEMPTS WERE MADE TO VERIFY FLOW, BUT NONE OF THEM WORKED INCLUDING USING THE OCCLUDE-PUMP-RELEASE TECHNIQUE AND INJECTING LIQUID INTO THE CERTAS PLUS RESERVOIR WHILE THE SHUNT INLET WAS OCCLUDED. EVENTUALLY A NEW CERTAS PLUS VALVE WAS USED AND IT DID FLOW AS EXPECTED. BOTH TIMES THE CERTAS PLUS WAS SET TO SETTING 4. THE VALVE ISSUE WAS DETECTED DURING IMPLANTATION PROCEDURE, AND THE EVENT LED TO APPROXIMATELY 5 MINUTES SURGICAL DELAY. SURGEON STATED THAT HE WAS NOT SURE THAT ISSUE WAS CAUSED BY THE CERTAS PLUS SHUNT AS THIS WAS A RELATIVELY COMPLEX SHUNT CASE. THE CERTAS PLUS VALVE WAS USED WITH: VENTRICULAR CATHETER (MEDTRONIC 44104), CSF RESERVOIR (MEDTRONIC 44104), AND PERITONEAL CATHETER FROM MEDTRONIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20274618 ↗
• InjuryMay 2, 2024No Flow; No Flow

  A FACILITY REPORTED A CERTAS VALVE (ID 828800PL) WAS NOT FLOWING. PHYSICIAN TRIED TO SET THE PRESSURE TO 5 AND ENDED IN 4. THE VALVE WAS EXPLANTED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 19234557 ↗
• MalfunctionApr 11, 2024Pressure Problem; Pressure Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091177 ↗
• InjuryFeb 20, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A FACILITY REPORTED A CERTAS VALVE (ID 828800PL) WAS UNABLE TO CHANGE SETTING AFTER IMPLANTATION PROCEDURE. THE PHYSICIAN ATTEMPTED TO PROGRAM THE VALVE TO A DIFFERENT SETTING, BUT IT REMAINED UNCHANGEABLE. AS A RESULT, THE SURGEON HAD TO REMOVE THE VALVE FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18740863 ↗
• InjuryFeb 7, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  N/A.

  Patient problems: Dizziness; Nausea

  MAUDE report 18664029 ↗
• InjuryDec 18, 2023Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A FACILITY REPORTED THAT A CERTAS VALVE (ID 828800PL) SEEMS TO BE STUCK AFTER BEING IMPLANTED VIA VENTRICULOPERITONEAL SHUNT AND WAS UNABLE TO REPROGRAM WITH MANUAL NOR ELECTRONIC TOOL KIT. THE PATIENT UNDERWENT SHUNT REVISION.

  Patient problems: Insufficient Information

  MAUDE report 18346058 ↗
• MalfunctionAug 22, 2023Contamination; Contamination

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596155 ↗
• InjuryJul 27, 2023Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A FACILITY REPORTED A CERTAS VALVE (ID (B)(4)) WAS IMPLANTED ON (B)(6) 2020 AND THE SURGEON HAD AN ISSUE IN WHICH THE CERTAS VALVE WAS UNABLE TO BE CHANGED FROM SETTING NUMBER 5 DESPITE MULTIPLE ATTEMPTS WITH DIFFERENT PROGRAMMERS. THE VALVE WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17408938 ↗
• InjuryJun 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERTAS VALVE (ID 828800PL) WAS IMPLANTED IN (B)(6) 2023, COMPLICATED BY A HYGROMA AND THEN A SUBDURAL HEMATOMA. THE VALVE CHANGED SETTINGS WITHOUT INTERVENTION. THE SHUNT WAS TURNED TO 8, AND WHEN VENTRICLES BLEW UP, THE HEMATOMA WAS EVACUATED. BEFORE DISCHARGE, THE PATIENT HAD CT SCAN THAT SHOWED VERY SMALL VENTRICLES. X-RAY OF THE VALVE LOOKED LIKE 8 BUT A LITTLE OFF. IT WAS ADJUSTED AGAIN TO 8, HOWEVER, THEY THINK THEY DIDN'T DO ANYTHING. THE PATIENT WAS DISCHARGED AND WAS BACK THE NEXT DAY WITH LARGE VENTRICLES AGAIN. ON (B)(6) 2023, MEDICAL STAFF CHANGE THE VALVE TO 7/8 AND CONFIRMED ON XRAY. THE PATIENT HAS HAD A DIFFICULT COURSE; THEREFORE, IT WAS TAKING IT DOWN TO 6/8, HOWEVER, ON (B)(6) 2023 X-RAY SHOWED THE VALVE WAS AT 8/8. IT WAS ADJUSTED DOWN TO 6/8, HOWEVER, X-RAY LATER THAT DAY SHOWED IT IS AT 5/8. THE VALVE WAS REMOVED AND REPLACED WITH CERTAS PLUS SIPHONGUARD ON (B)(6) 2023. ACCORDING TO INFORMATION PROVIDED: MEDICAL STAFF BELIEVE THE VALVE WAS ACCEPTABLE WHEN INITIALLY IMPLANTED, BUT FAILED AFTER 6 WEEKS OF BEING IMPLANTED. IT IS POTENTIALLY HARD TO DETERMINE IF THE VALVE MALFUNCTIONED AS THERE ARE MANY FACTORS SUCH AS HUMAN ERROR WITH PROGRA

  Patient problems: Coma

  MAUDE report 17171865 ↗
• InjuryApr 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPORTED A CERTAS VALVE (ID 828800PL) WAS IMPLANTED AND THE PATIENT WAS BROUGHT BACK TO SURGERY HOURS LATER TO REPLACE THE VALVE. ACCORDING TO REPORTER: "VALVE WAS EITHER NOT FLOWING PROPERLY OR THERE WAS A PINCH IN THE CATHETER LEADING TO VENTRICLE. I BELIEVE IT WAS PINCHED BUT TO BE CERTAIN WE SWAPPED THE VALVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686325 ↗