CODMAN CERTAS® Plus 828810PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10381780529316), received between Oct 21, 2022 and Mar 6, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED THAT A CODMAN CERTAS VALVE (ID (B)(6)) WAS IMPLANTED ON (B)(6) 2026. VALVE INITIAL SETTING NOT AVAILABLE. IT WAS REPORTED THAT THE VALVE SETTINGS CHANGED POST-IMPLANTATION. THE SETTINGS WERE RESET; HOWEVER, THEY CHANGED AGAIN. THE MOST RECENT SETTING CHANGE WAS IDENTIFIED WHILE THE INDIVIDUAL WAS AT HOME. VALVE SETTINGS WERE VERIFIED USING A PROGRAMMING TOOL. NO INCIDENT INVOLVING SIGNIFICANT ACCELERATION OR DECELERATION (E.G., MOTOR VEHICLE ACCIDENT OR FALL) WAS REPORTED. THE VALVE WAS SUBSEQUENTLY REMOVED AND REPLACED ON (B)(6) 2026. THE INDIVIDUAL'S CONDITION WAS REPORTED AS STABLE AND DISCHARGED HOME.

  Patient problems: Insufficient Information

  MAUDE report 24532761 ↗
• InjuryJan 7, 2026Failure to Align

  NA.

  Patient problems: Insufficient Information

  MAUDE report 23988178 ↗
• InjuryJun 14, 2024Failure to Align; Failure to Align

  A FACILITY REPORTED A CERTAS PLUS VALVE WAS IMPLANTED ON (B)(6) 2021. IN (B)(6) 2024, THE SETTING CHANGED SPONTANEOUSLY AFTER MRI. IT SEEMS TO NOT LOCK INTO INDIVIDUAL SETTINGS SLOT, THE VALVE SPINS FREELY CAUSING MINIMAL INCREASE IN CERVICAL SYRINX.ACCORDING TO INFORMATION PROVIDED, REVISION/MEDICAL INTERVENTION WAS REQUIRED, HOWEVER, IT IS UNKNOWN WHAT TYPE OF INTERVENTION WAS REQUIRED.

  Patient problems: Cyst(s)

  MAUDE report 19538709 ↗
• InjuryMay 24, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A FACILITY REPORTED A CERTAS VALVE (ID 828810PL) WAS IMPLANTED ON (B)(6) 2023. THE VALVE SETTING WAS SUCCESSFULLY CHANGED FROM 1 TO 2 ON (B)(6) 2024. ON (B)(6) , 2024, AFTER CHECKING AGAIN, THE VALVE WAS SET TO 1. THE VALVE WAS STUCK AT LEVEL 1 AND COULD NOT BE ADJUSTED, DESPITE NUMEROUS ATTEMPTS BY VARIOUS PROGRAMMERS. THE PATIENT DID NOT PRESENTED SIGNS AND SYMPTOMS DUE TO VALVE FAILURE. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED AND IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391942 ↗
• InjuryApr 5, 2024Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED A CERTAS VALVE (ID 828810PL) WAS SUSPECTED OF HAVING PROTEIN BUILD UP AND IMPROPER PRIMING. THE PATIENT WAS NOT DRAINING. THE VALVE WAS IMPLANTED 2 WEEKS PRIOR TO THIS REPORT AND HAS HAD COMPLICATIONS SINCE BEING DISCHARGED FROM THE HOSPITAL. THE VALVE WAS REMOVED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: Insufficient Information

  MAUDE report 19054337 ↗
• InjuryJun 1, 2023Failure to Read Input Signal; Failure to Read Input Signal

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038595 ↗
• InjuryMay 16, 2023No Flow; No Flow

  N/A

  Patient problems: Insufficient Information

  MAUDE report 16942085 ↗
• MalfunctionFeb 16, 2023Output Problem; Output Problem

  N/A

  Patient problems: Insufficient Information

  MAUDE report 16386959 ↗
• InjuryFeb 7, 2023Obstruction of Flow; Output Problem; Obstruction of Flow; Output Problem

  A FACILITY REPORTED A CERTAS VALVE (ID 828811PL) WAS IMPLANTED ON (B)(6) 2022 WITH SETTING 1 (25 MMH20). DURING THE CLINIC CHECKUP THE VALVE WAS FOUND TO BE "STUCK". THERE WERE SEVERAL ATTEMPTS TO CHANGE THE VALVE TO THE DESIRED SETTING. A DECISION WAS MADE TO EXPLANT THE VALVE AND TEST THE COMPONENTS TO FIND THE CAUSE OF THE ISSUES. VENTRICULAR CATHETER WAS OCCLUDED. THE VALVE HAD SOME BLOCKAGE AND MANOMETER WAS CLOSED AROUND 85 MMH2O (HIGH FOR SETTING 1 PROBABLY A RESULT OF CATHETER OCCLUSION). THE VALVE WAS EXPLANTED AND TESTED AT 25MMH2O. A NEW VALVE WAS IMPLANTED AT SETTING 3 (80 MMH2O).

  Patient problems: Insufficient Information

  MAUDE report 16312098 ↗
• InjuryDec 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED A CERTAS VALVE (ID 828810PL ) FAILED IN A PEDIATRIC PATIENT DUE TO YELLOWISH BUILD UP ON DISTAL END OF VALVE. THE VALVE WAS ACCEPTABLE UPON INITIAL IMPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 15981306 ↗
• MalfunctionNov 6, 2022Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15741451 ↗
• InjuryOct 21, 2022Pressure Problem; Pressure Problem

  THIS IS 5 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00471, 3013886523-2022-00472, 3013886523-2022-00473, 3013886523-2022-00474. A PHYSICIAN REPORTED AN UNKNOWN CERTAS VALVE WAS IMPLANTED IN A 20 MONTH-OLD FEMALE PATIENT ON (B)(6) 2022. THE VALVE WAS FOUND AT AN INCORRECT SETTING AFTER MRI USING BOTH HAND HELD AND MANUAL DEVICES ON MULTIPLE DATES ((B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022). THEREFORE, THE VALVE WAS REMOVED. NOTE: ALTHOUGH ONLY ONE VALVE WAS REMOVED, FIVE REPORTS HAVE BEEN OPENED FOR THIS EVENT BECAUSE IT IS UNKNOWN IF THE VALVE REMAINED WITH THE WRONG SETTING DURING 10 DAYS, OR IF THE SETTING WAS CORRECTED/ADJUSTED EACH TIME IT WAS FOUND INCORRECT (5 OCCASIONS). A REQUEST FOR CLARIFICATION WAS SENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. OUR REASONING IS THAT THE VALVE CHANGED THE SETTING IN 5 OCCASIONS.

  Patient problems: Insufficient Information

  MAUDE report 15650321 ↗
• InjuryOct 21, 2022Pressure Problem; Pressure Problem

  THIS IS 3 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00471, 3013886523-2022-00472, 3013886523-2022-00474, 3013886523-2022-00475. A PHYSICIAN REPORTED AN UNKNOWN CERTAS VALVE WAS IMPLANTED IN A 20 MONTH-OLD FEMALE PATIENT ON (B)(6) 2022. THE VALVE WAS FOUND AT AN INCORRECT SETTING AFTER MRI USING BOTH HAND HELD AND MANUAL DEVICES ON MULTIPLE DATES ((B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022). THEREFORE, THE VALVE WAS REMOVED. NOTE: ALTHOUGH ONLY ONE VALVE WAS REMOVED, FIVE REPORTS HAVE BEEN OPENED FOR THIS EVENT BECAUSE IT IS UNKNOWN IF THE VALVE REMAINED WITH THE WRONG SETTING DURING 10 DAYS, OR IF THE SETTING WAS CORRECTED/ADJUSTED EACH TIME IT WAS FOUND INCORRECT (5 OCCASIONS). A REQUEST FOR CLARIFICATION WAS SENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. OUR REASONING IS THAT THE VALVE CHANGED THE SETTING IN 5 OCCASIONS.

  Patient problems: Insufficient Information

  MAUDE report 15650314 ↗
• InjuryOct 21, 2022Pressure Problem; Pressure Problem

  THIS IS 4 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00471, 3013886523-2022-00472, 3013886523-2022-00473, 3013886523-2022-00475. A PHYSICIAN REPORTED AN UNKNOWN CERTAS VALVE WAS IMPLANTED IN A 20 MONTH-OLD FEMALE PATIENT ON (B)(6) 2022. THE VALVE WAS FOUND AT AN INCORRECT SETTING AFTER MRI USING BOTH HAND HELD AND MANUAL DEVICES ON MULTIPLE DATES ((B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022). THEREFORE, THE VALVE WAS REMOVED. NOTE: ALTHOUGH ONLY ONE VALVE WAS REMOVED, FIVE REPORTS HAVE BEEN OPENED FOR THIS EVENT BECAUSE IT IS UNKNOWN IF THE VALVE REMAINED WITH THE WRONG SETTING DURING 10 DAYS, OR IF THE SETTING WAS CORRECTED/ADJUSTED EACH TIME IT WAS FOUND INCORRECT (5 OCCASIONS). A REQUEST FOR CLARIFICATION WAS SENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. OUR REASONING IS THAT THE VALVE CHANGED THE SETTING IN 5 OCCASIONS.

  Patient problems: Insufficient Information

  MAUDE report 15650305 ↗
• InjuryOct 21, 2022Pressure Problem; Pressure Problem

  THIS IS 1 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00472, 3013886523-2022-00473, 3013886523-2022-00474, 3013886523-2022-00475. A PHYSICIAN REPORTED AN UNKNOWN CERTAS VALVE WAS IMPLANTED IN A 20 MONTH-OLD FEMALE PATIENT ON (B)(6) 2022. THE VALVE WAS FOUND AT AN INCORRECT SETTING AFTER MRI USING BOTH HAND HELD AND MANUAL DEVICES ON MULTIPLE DATES ((B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022). THEREFORE, THE VALVE WAS REMOVED. NOTE: ALTHOUGH ONLY ONE VALVE WAS REMOVED, FIVE REPORTS HAVE BEEN OPENED FOR THIS EVENT BECAUSE IT IS UNKNOWN IF THE VALVE REMAINED WITH THE WRONG SETTING DURING 10 DAYS, OR IF THE SETTING WAS CORRECTED/ADJUSTED EACH TIME IT WAS FOUND INCORRECT (5 OCCASIONS). A REQUEST FOR CLARIFICATION WAS SENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. OUR REASONING IS THAT THE VALVE CHANGED THE SETTING IN 5 OCCASIONS.

  Patient problems: Insufficient Information

  MAUDE report 15650302 ↗
• InjuryOct 21, 2022Pressure Problem; Pressure Problem

  THIS IS 2 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00471, 3013886523-2022-00473, 3013886523-2022-00474, 3013886523-2022-00475. A PHYSICIAN REPORTED AN UNKNOWN CERTAS VALVE WAS IMPLANTED IN A 20 MONTH-OLD FEMALE PATIENT ON (B)(6) 2022. THE VALVE WAS FOUND AT AN INCORRECT SETTING AFTER MRI USING BOTH HAND HELD AND MANUAL DEVICES ON MULTIPLE DATES ((B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, (B)(6) 2022). THEREFORE, THE VALVE WAS REMOVED. NOTE: ALTHOUGH ONLY ONE VALVE WAS REMOVED, FIVE REPORTS HAVE BEEN OPENED FOR THIS EVENT BECAUSE IT IS UNKNOWN IF THE VALVE REMAINED WITH THE WRONG SETTING DURING 10 DAYS, OR IF THE SETTING WAS CORRECTED/ADJUSTED EACH TIME IT WAS FOUND INCORRECT (5 OCCASIONS). A REQUEST FOR CLARIFICATION WAS SENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. OUR REASONING IS THAT THE VALVE CHANGED THE SETTING IN 5 OCCASIONS.

  Patient problems: Insufficient Information

  MAUDE report 15650301 ↗