CODMAN CERTAS 82-8800PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704079002), received between Dec 21, 2018 and Feb 27, 2024 — classified as 1 death, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Dizziness

  MAUDE report 18787811 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 6, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A FACILITY REPORTED A CERTAS VALVE WOULD NOT DRAIN. NO PATIENT INJURY REPORTED. THE VALVE WAS USED TO TREAT NORMAL PRESSURE HYDROCEPHALUS. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13174743 ↗
• MalfunctionDec 21, 2018Self-Activation or Keying

  THE PATIENT HAD A PROGAV SHUNT VALVE FOR VPS. IT WAS DISCOVERED THAT THIS VALVE CHANGED SETTING ON ITS OWN, WITHOUT BEING PROGRAMMED. WE WERE ALSO UNABLE TO RE-PROGRAM THE VALVE IN THE CLINICAL SETTING. IT WAS CONCLUDED THAT VALVE WAS MALFUNCTIONING AND PATIENT WAS TAKEN TO THE OPERATING ROOM TO REMOVE PROGAV VALVE AND EXCHANGE FOR A CERTAS PLUS VALVE.

  Patient problems: No Code Available

  MAUDE report 8189267 ↗