CODMAN CERTAS® Plus 828804PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN CERTAS® Plus Programable Valve Inline Valve Only with SIPHONGUARD® Includes: Priming Adapter and Information Manual · Class 2 · Implant
Quick summary
This is the Codman Certas Plus programmable valve, an implanted shunt component that regulates fluid flow in the brain. The 38 reports mostly describe the valve breaking or not draining fluid properly, along with fluid or blood leaking around the shunt, pressure problems, and headaches. Reports include 1 death and 34 injuries. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 1
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10381780521174), received between Jul 23, 2021 and Aug 7, 2026 — classified as 1 death, 34 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information7
- Break6
- Obstruction of Flow4
- Fluid/Blood Leak3
- Crack2
- Failure to Align2
- Improper Flow or Infusion2
- Infusion or Flow Problem2
Patient problems
- Insufficient Information14
- Headache5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Cerebral Ventriculomegaly3
- Cerebrospinal Fluid Leakage3
- No Clinical Signs, Symptoms or Conditions3
- Cerebral Edema2
- Dizziness2
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Fracture
A facility reported a Certas valve (b)(6) was implanted on (b)(6) 2023. The valve was fractured at the interface of the reservoir and anti-siphon. The patient was pumping the shunt valve at home, but no injury or fall reported. The patient was symptomatic from non-functioning shunt (headaches, dizziness, imbalance, and memory issues), and nuclear medicine (NM) scan showed shunt malfunction, therefore, the valve was explanted on (b)(6) 2026.
Patient problems: Dizziness; Headache; Memory Loss/Impairment
MAUDE report 50175250 ↗DeathMar 30, 2026Improper Flow or Infusion
InjuryMar 17, 2026Obstruction of Flow
A PHYSICIAN REPORTED: "ON (B)(6), THE PATIENT HAD AN EXTERNAL VENTRICULAR DRAIN (EVD) REMOVED AND A CERTAS VALVE IMPLANTED, DRAINING FROM THE OTHER VENTRICLE. OVER THE WEEKEND, IT WAS DISCOVERED THAT THE PATIENT WAS LEAKING CEREBROSPINAL FLUID (CSF) FROM THE EVD INCISION. THEY CONCLUDED THAT THE SHUNT WAS NOT DRAINING PROPERLY. ON (B)(6), A SHUNT REVISION WAS CONDUCTED. THE SHUNT WAS TESTED PRIOR TO EXPLANT. CSF WAS NOT FLOWING FROM THE DISTAL CATHETER OR THE DISTAL END OF THE VALVE. WHEN THE SHUNT WAS DISCONNECTED FROM THE VENTRICULAR CATHETER, CSF FLOWED FREELY. A SECOND SHUNT (ID 828814PL) WAS CONNECTED TO THE VENTRICULAR CATHETER. A MANOMETER WAS CONNECTED TO THE DISTAL END OF THE SHUNT. THIS TIME, CSF SEEMED TO FLOW MUCH FASTER THROUGH THE VALVE THAN EXPECTED AND THE VALVE WAS NOT REGULATING FLOW. THE ISSUE WAS DETECTED BEFORE IMPLANTATION SITE CLOSURE AND LED TO FIVE-MINUTE DELAY. A THIRD SHUNT WAS CONNECTED (ID 828810PL) TO THE VENTRICULAR CATHETER. THIS SHUNT ALSO DEMONSTRATED SOME SORT OF ISSUE WITH CSF FLOW. THEY CANNOT REMEMBER EXACTLY WHAT THE ISSUE WAS. THE ISSUE WITH THE THIRD VALVE WAS DETECTED BEFORE IMPLANTATION SITE CLOSURE AND LED TO FIVE-MINUTES DELAY. A FOURTH
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24616383 ↗InjuryFeb 27, 2026Obstruction of Flow
A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804PL) WAS IMPLANTED IN (B)(6) 2024 AT SETTING 3 DUE TO HYDROCEPHALUS. THE VALVE WORKED WELL UNTIL AROUND (B)(6) 2025 WHEN THE PATIENT BEGAN HAVING ISSUES LIKE FREQUENT FALLS. CLINICIANS CHANGED SETTING TO 2. THE PATIENT STILL HAD LARGE VENTRICLES AND SHUNT STUDY CONFIRMED THAT FLUID WAS NOT FLOWING PROPERLY THROUGH THE VALVE. MANOMETER CONFIRMED DURING REVISION SURGERY THAT VALVE WAS NOT WORKING PROPERLY, THEREFORE, THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2026.
Patient problems: Balance Problems
MAUDE report 24469567 ↗InjuryFeb 13, 2026Crack
InjuryDec 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionDec 12, 2025Failure to Align; Failure to Align
InjuryDec 5, 2025Failure to Align; Failure to Align
InjuryNov 7, 2025Break; Break
InjuryJul 25, 2025Obstruction of Flow; Obstruction of Flow
InjuryMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
2 OF 3 REPORTS (SAME PRODUCT FAILURE, DIFFERENT PATIENTS). OTHER MFG REPORT NUMBERS: 3013886523-2025-00100. 3013886523-2025-00098. A FACILITY REPORTED A CERTAS VALVE (ID 828804PL) WAS IMPLANTED ON (B)(6) 2021. ON (B)(6) 2025, A MAGNETIC RESONANCE IMAGING (MRI) REVEALED THAT THE SIPHON GUARD HAD COMPLETELY DETACHED FROM BODY OF VALVE, REQUIRING REVISION SURGERY FOR EXPLANTATION AND REPLACEMENT. THE PATIENT DID NOT PRESENT SIGNS AND SYMPTOMS DUE TO VALVE FAILURE. CURRENT STATUS OF THE PATIENT - NO LONG-TERM DAMAGE.
Patient problems: Insufficient Information
MAUDE report 22010024 ↗InjuryMar 21, 2025Improper Flow or Infusion; Improper Flow or Infusion
A FACILITY REPORTED: "VALVE (ID 828804PL) WAS SET TO 8, SHUNT STUDY SHOWING FLUID STILL FLOWING THROUGH VALVE INTO DISTAL CATHETER AND INTO ATRIA WHERE DISTAL CATHETER PLACED." VALVE WAS PLACED VIA VENTRICULOPERITONEAL SHUNT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 21664950 ↗InjuryOct 4, 2024Break; Break
MalfunctionAug 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A CERTAS VALVE (ID 828804PL) WAS LEAKING CEREBROSPINAL FLUID (CSF) AT THE TOP OF THE RESERVOIR. THE ISSUE WAS NOTICED AS THE SURGEON WAS PREPARING TO CLOSE THE SITE AND STATED THAT AS IF THERE WAS A HOLE IN IT. THE EVENT LED TO 30-MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 19950118 ↗InjuryJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A FACILITY REPORTED A CERTAS PLUS VALVE WAS IMPLANTED ON (B)(6) 2024 4 DUE TO HYDROCEPHALUS. THE PATIENT RETURNED AND A NEW VALVE WAS IMPLANTED. SURGEON SUSPECTS THE VALVE WAS DEFECTIVE. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19590014 ↗InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A FACILITY REPORTED A CERTAS VALVE (ID 828804PL) WAS NOT WORKING. THEREFORE, A REVISION SURGERY WAS PERFORMED, AND THE VALVE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. THERE IS NO DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT AND PRODUCT PROBLEM.
Patient problems: Insufficient Information
MAUDE report 19538710 ↗InjuryJun 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryMay 9, 2024Material Separation; Material Separation
InjuryMar 24, 2024Break; Break
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2024-00091 A FACILITY REPORTED AN ELEVEN YEAR-OLD PATIENT WITH AN EXTENSIVE MEDICAL AND SURGICAL HISTORY PRESENTED WITH NEW SYRINX, UNDERWENT A REDO CHIARI AND SINCE THEY THOUGHT HE WAS OVER SHUNTING FROM HIS CERTAS (UNKNOWN ID-WITHOUT SIPHONGUARD), THEY DECIDED TO TRANSITION HIM TO A SIPHONGUARD ON (B)(6) 2024 ((B)(6)) . THE PATIENT THEN PRESENTED ON (B)(6) 2024, WITH A SUBGALEAL FLUID COLLECTION AND A BROKEN VALVE. WHEN THEY EXCHANGED HIM TO A NEW VALVE, THEY DRILLED A TROUGH FOR THE VALVE IN HIS CALVARIUM, SO NOW THE VALVE SITS IN A WALL OF BONE. HE IS NONVERBAL AUTISTIC AND DOES HAVE SELF-HITTING BEHAVIOR. THEY ARE NOT SURE IF HE BROKE HIS VALVE. THE BROKEN VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024, WITH ANOTHER NEW (B)(6).
Patient problems: Swelling/ Edema
MAUDE report 18966525 ↗InjuryJan 11, 2024Infusion or Flow Problem; Infusion or Flow Problem
InjuryJan 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
InjuryNov 14, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804PL) WAS FLOWING VERY SLOW FOR THE SETTING IT WAS PROGRAMMED TO; THEREFORE IT WAS EXPLANTED ON (B)(6) 2023. THE ISSUE WAS FOUND AFTER IMPLANTATION (DATE UNKNOWN). THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE WITH NO ISSUES.
Patient problems: Insufficient Information
MAUDE report 18130216 ↗InjurySep 14, 2023Obstruction of Flow; Obstruction of Flow
A FACILITY REPORTED A PATIENT WAS EXPERIENCING ENLARGED VENTRICLES WITH CERTAS VALVE SETTING 1. MEDICAL STAFF TAPPED THE RESERVOIR AND THEY WERE GETTING PRESSURE AND FLOW. THEY REVISED THE SHUNT AND DETERMINED DURING THAT PROCEDURE THAT THE DISTAL CATHETER WAS FLOWING FINE. THE CERTAS VALVE WAS IMPLANTED ON (B)(6), 2023 AND EXPLANTED/REPLACED ON (B)(6), 2023.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 17744024 ↗InjuryAug 8, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
N/A
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17483969 ↗InjuryJul 6, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
A FACILITY REPORTED THE ANTI-SIPHON OF A CERTAS PLUS VALVE (ID (B)(4)) BROKE AND CEREBROSPINAL FLUID (CSF) WAS LEAKING FROM THE BRAIN. ACCORDING TO REPORTER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 17273863 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.