CODMAN CERTAS SIPHONGUARD 82-8804PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886704079040), received between Jul 23, 2018 and May 14, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A CUSTOMER REPORTED A CERTAS VALVE (ID 828800PL) WAS IMPLANTED ON (B)(5)2024. SHORTLY AFTER THE IMPLANTATION, THE PATIENT EXPERIENCED MULTIPLE EPISODES OF MIGRAINE (DIFFERING FROM HER TYPICAL MIGRAINES), LETHARGY TO THE POINT OF LOSS OF COGNITION FOR UP TO 72 HOURS, AND PULSATING PAIN IN THE AREA OF THE SHUNT. THESE SYMPTOMS WERE CONSISTENT WITH THE PATIENT¿S PAST EXPERIENCES OF INTERMITTENT SHUNT FAILURE.THE PATIENT HAD MULTIPLE VISITS TO THE EMERGENCY ROOM AND ULTIMATELY SPENT 19 DAYS IN NEURO CRITICAL CARE. AS A RESULT, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2025. THE VALVE REPLACEMENT INITIALLY RESULTED IN THE ELIMINATION OF SYMPTOMS, AND THE PATIENT REPORTED FEELING REMARKABLY BETTER FOLLOWING THE SURGERY. HOWEVER, SOME EPISODES HAVE OCCURRED SINCE, AND VALVE ADJUSTMENTS ARE STILL ONGOING.

  Patient problems: Cognitive Changes; Headache; Lethargy

  MAUDE report 22021079 ↗
• InjuryJun 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00237. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804PL) WAS IMPLANTED DUE TO SNPH (SECONDARY NORMAL PRESSURE HYDROCEPHALUS) VIA V-P SHUNT ON (B)(6) 2022 WITH UNKNOWN SETTING. IT WAS USED WITH BACTISEAL CATHETER (ID 823072). ON (B)(6) 2022, THE PATIENT DEVELOPED DISORIENTATION AND UNDERWENT AN X-RAY EXAMINATION, AND VENTRICULAR ENLARGEMENT WAS CONFIRMED. DUE TO A SUSPICION OF SHUNT FAILURE THE VALVE AND CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2022.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 14567458 ↗
• InjuryJun 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED A CERTAS VALVE (828804PL) WAS IMPLANTED ON (B)(6) 2020. THE PATIENT HAD SHUNT MALFUNCTION SYMPTOMS (UNKNOWN SYMPTOMS). A SURGICAL EXPLORATION WAS PERFORMED AND CEREBROSPINAL FLUID LEAKAGE WAS NOTED AT THE DISTAL END VALVE. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2020. THE PATIENT WAS DOING WELL AND DISCHARGED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 14566119 ↗
• InjuryMay 24, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A FACILITY REPORTED A CERTAS PLUS VALVE (ID 828804PL) WAS IMPLANTED IN A MALE PATIENT ON UNKNOWN DATE AND SETTING. PHYSICIAN WAS UNABLE TO CONFIRM THE CSF FLOW THROUGH THE VALVE. THEREFORE, THE VALVE WAS REPLACED AND FLOW WAS THEN CONFIRMED. A 30-MINUTE DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492770 ↗
• InjuryApr 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED THE CERTAS VALVE SEEM TO HAVE A LEAK. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14162014 ↗
• InjuryMar 17, 2022Mechanical Problem; Mechanical Problem

  A PHYSICIAN REPORTED A CERTAS PLUS VALVE WAS IMPLANTED ON (B)(6) 2021 WITH SETTING 4. THE PATIENT PRESENTED WITH INCREASE IN VENTRICLE SIZE. THE PHYSICIAN TRIED TO REPROGRAM THE VALVE TO 3 WITH A ETK AND THE VALVE STAYED AT 4. AFTER MANY ATTEMPTS INCLUDING WITH THE BASIC TOOL KIT AND LOW PROFILE TOOL, THE SETTING REMAINED AT 4. THE LARGE MAGNET COULDN¿T MOVE THE SETTING OFF OF 4. X-RAY CONFIRMED SETTING IS STUCK AT 4. THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6), 2022.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 13791619 ↗
• MalfunctionJan 7, 2022Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A PHYSICIAN REPORTED A CERTAS PLUS VALVE WAS IMPLANTED ON (B)(6) 2020, AND THE POSITION HAS NEVER BEEN ADJUSTED. IMMEDIATELY POSTOPERATIVELY THERE WAS BLOOD IN THE VENTRICLES, BUT THE DRAIN CERTAINLY DID HIS WORK. THE NEUROSURGEON WOULD LIKE TO MAKE IT GO FASTER NOW, BUT HE ISN¿T ABLE TO CHANGE THE POSITION. HE TRIED THE ANALOGY TOOL AND THE DIGITAL SYSTEM AND MAGNETS DIRECTLY ON THE SKIN AND NOTHING WORKED. THE LAST OPTION WAS AN MRI YESTERDAY WITH THE HOPE THE MAGNET COULD PULL SOMETHING OFF BUT DIDN¿T WORK. PRODUCT MANAGER AND SALES REP HAD A MEETING WITH THE SURGEON AND WHAT THEY UNDERSTOOD IT IS NOT A NORMAL HYDROCEPHALUS PERSON. THE PATIENT HAS NEUROFIBROMATOSIS IN THE EYE AND IS STABLE NOW. PRODUCT MANAGER ASKS ALL THE STEPS WHICH NEEDS TO BE DONE BEFORE TAKING THE STEP TO CHANGE THE VALVE AND THE CONCLUSION IS THEY DID EVERYTHING TO ADJUST A NEW SETTING, BUT IT DIDN¿T WORK. COMMENTS FROM SURGEON: "THE BIGGEST PROBLEM IS THAT HE HAS THE SHUNT TO DECREASE AN ARACHNOID CYST BEHIND THE ORBIT. THIS ARACHNOID CYST PUSHES HIS EYEBALL OUTWARDS. AFTER PLACEMENT OF THE SHUNT THIS DECREASED, NOW IT HAS INCREASED AGAIN, THIS IS THE REASON WHY I WANT TO DECREASE THE RESISTANCE SETTING O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195178 ↗
• InjuryMay 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERTAS VALVE WAS IMPLANTED ON (B)(6) 2018 AND IMAGING ON (B)(6) 2020 DEMONSTRATED MILD VENTRICULAR ENLARGEMENT. FOLLOW-UP IMAGING ON (B)(6) 2021 DEMONSTRATED; SIGNIFICANT INTERVAL INCREASE NOTED IN VENTRICULAR ENLARGEMENT. THIS IMAGING PROMPTED AN XRAY WHICH DEMONSTRATED THE VALVE SETTING HAD CHANGED FROM 2 TO 6. TO DATE, ALL THE PATIENTS VISITS RELATED TO HYDROCEPHALUS HAVE BEEN AT ONE FACILITY WHERE THEY DID NOT CHANGE THE PATIENTS SETTING. THE FACILITY REPORTED THIS WOULD SUGGEST THAT THE SETTING CHANGE WAS NOT PLANNED. THE PRODUCT HAS NOT BEEN EXPLANTED AND THE VALVE WAS NOT REPLACED. THE PATIENT REMAINS CLINICALLY STABLE. ON (B)(6) 2021, THE VALVE WAS DIALED DOWN FROM 6 (INCORRECT SETTING) TO 4 WITH A PLAN TO DIAL DOWN FROM 4 TO 2 (APPROPRIATE SETTING) IN 4-6 WEEKS.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 11779376 ↗
• MalfunctionMar 12, 2021Output Problem; Output Problem

  A FACILITY REPORTED AN UNINTENDED SHUNT VALVE SETTING CHANGE AFTER AN MRI. A CERTAS VALVE WAS PLACED VIA VENTRICULAR PERITONEAL SHUNT IN A PATIENT ON (B)(6) 2019. THE PATIENT HAD AN XR PERFORMED PRIOR TO MRI OF LUMBAR SPINE ON (B)(6) 2021 SHOWING THE VALVE AT 7. THE PATIENT HAD AN MRI LUMBAR SPINE WITH AN OUTSIDE PROVIDER ON (B)(6) 2021, AFTER WHICH THE PATIENTS PRIMARY NEUROSURGEON RECEIVED A CALL FROM THE PATIENT THAT THEIR CERTAS VALVE HAD CHANGED FROM 7 TO 8 DURING THE MRI. SKULL FILMS WERE NOT CLEAR TO THE NEUROSURGEON. THE NEUROSURGEON HAD THE PATIENT REPEAT SKULL FILMS IN THEIR NEUROSURGERY CLINIC AND COME IN PERSON FOR EVALUATION. REPORTEDLY THE PATIENT WAS NOT SYMPTOMATIC. THE PROGRAMMER CONFIRMED THE VALVE WAS AT 8, THE NEUROSURGERY OFFICE STAFF DIALED THE SHUNT VALVE BACK DOWN TO 7 WITHOUT DIFFICULTY. THE PATIENT REPORTEDLY IS AT THEIR BASELINE FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477687 ↗
• MalfunctionJul 23, 2018Obstruction of Flow; Obstruction of Flow

  AS REPORTED BY THE SALES REP, A CERTAS PLUS VALVE WITH SIPHONGUARD WAS OCCLUDED AND HAD NO FLOW DURING THE IMPLANTATION PROCEDURE. A NON-CODMAN VALVE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7709973 ↗