CODMAN CERTAS PlusRecalls & reported problems across all models
Integra LifeSciences Switzerland Sàrl · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 113
- Deaths reported
- 1
- Injuries reported
- 94
- Recalls
- 0
We found 14 models of CODMAN CERTAS Plus by Integra LifeSciences Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 113 adverse event reports in the FDA's MAUDE database, received between Jul 23, 2021 and Aug 7, 2026 — classified as 1 death, 94 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CODMAN CERTAS Plus problems
Device problems
- Insufficient Device Problem Information21
- Break10
- Obstruction of Flow9
- Pressure Problem8
- Device Difficult to Program or Calibrate7
- Infusion or Flow Problem7
- No Flow7
- Improper Flow or Infusion6
Patient problems
- Insufficient Information57
- No Clinical Signs, Symptoms or Conditions16
- Headache10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Dizziness5
- Vomiting5
- Cerebral Ventriculomegaly4
- Cerebrospinal Fluid Leakage4
CODMAN CERTAS Plus models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CODMAN CERTAS® Plus 828804PLShunt, central nervous system and components1 death38 reports
- CODMAN CERTAS® Plus 828814PLShunt, central nervous system and components27 reports
- CODMAN CERTAS® Plus 828810PLShunt, central nervous system and components16 reports
- CODMAN CERTAS® Plus 828800PLShunt, central nervous system and components14 reports
- CODMAN CERTAS® Plus 828805PLShunt, central nervous system and components4 reports
- CODMAN CERTAS® Plus 828803PLShunt, central nervous system and components3 reports
- CODMAN CERTAS® Plus 828807PLShunt, central nervous system and components3 reports
- CODMAN CERTAS® Plus 828824PLShunt, central nervous system and components2 reports
- CODMAN CERTAS® Plus 828801PLShunt, central nervous system and components1 report
- CODMAN CERTAS® Plus 828817PLShunt, central nervous system and components1 report
- CODMAN® CERTAS® Plus 828807PLShunt, central nervous system and components1 report
- CODMAN® CERTAS® Plus 828813PLShunt, central nervous system and components1 report
- CODMAN® CERTAS® Plus 828817PLShunt, central nervous system and components1 report
- CODMAN® CERTAS® Plus 828827PLCATHETER, VENTRICULAR1 report
Recent CODMAN CERTAS Plus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Improper Flow or Infusion
A sales representative stated:"Patient is a 68-year-old man with normal pressure hydrocephalus. He was shunted in December 2025 and has been having unpredictable responses to valve changes ever since. Patient had subdurals that had to be managed, but not surgically. Recently, his ventricles had collapsed down with small extra axial collections. The physician turned the valve off to 8 and his ventricles remained collapsed with small extra axial collections. He was neurologically doing very well but was having low pressure headaches.""The physician assumed that the valve was defective now that it was set at 8 and the ventricles were not filling up. He felt the valve was probably just staying open and continued to drain. Ultimately, with the postural headaches continuing, the physician really didn't like looking at slit ventricles and small axials so with the hypothesis of the defective valve, the valve being stuck open, despite being set at 8, the physician put him on the schedule to replace what he thought was a defective valve. That was scheduled for next week, but yesterday on (b)(6), he came in with asymptomatic hydro. Images were close to his pre-op scan. The physician reprogram
Patient problems: Headache
MAUDE report 50175253 ↗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 ↗InjuryAug 4, 2026Disconnection; Unintended System Motion; Expulsion
A facility reported a Certas valve (ID: 828817PL) changed settings:On (b)(6) 2025, it was programmed to 2. On (b)(6) 2026, the patient underwent an X-ray and presented to the emergency room (ER) with a suspected shunt malfunction. A computed tomography (CT) scan performed the same day revealed a shunt disconnection. The right frontal approach ventricular catheter tip had migrated to the suprasellar cistern in the vicinity of the optic chiasm, and the proximal aspect of the ventricular catheter appeared detached from the shunt valve. The ventricular caliber had slightly increased, particularly in the temporal horns, which may reflect developing hydrocephalus. Also on (b)(6) 2026, the patient underwent magnetic resonance imaging (MRI). Following the MRI, the patient was taken to the operating room (OR) to reattach the catheter to the valve. In the operating room, the Medtronic Strata Programming Tool was erroneously used to reset the shunt to 2.0 (a Medtronic setting, not a Certas Plus setting). However, an X-ray taken on (b)(6) 2026, revealed that the Certas valve was set to 4. The patient was exposed to a 1.5T GE magnet.
Patient problems: Insufficient Information
MAUDE report 50130372 ↗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 ↗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 ↗InjuryFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A CERTAS VALVE (ID (B)(6)) WAS IMPLANTED ON (B)(6) AND THEN REMOVED AND REPLACED DUE TO AN INCREASE IN INTRACRANIAL PRESSURE (ICP). AS PER REPORTER, THE PATIENT EXPERIENCED SIGNS AND SYMPTOMS OF INCREASED ICP, HOWEVER, DETAILS WERE NOT PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24469894 ↗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 27, 2026Obstruction of Flow
THIS IS 1 OF 2 REPORTS (SAME PATIENT, DIFFERENT VALVES) LINKED TO MFG REPORT NUMBER: 3013886523-2026-00039. A FACILITY REPORTED A CERTAS VALVE (ID 828827PL) WAS IMPLANTED ON (B)(6), 2026, PROGRAMMED AT 4. THE PATIENT HAD SYMPTOMATIC RELIEF POST PROCEDURE. THE PATIENT WENT HOME WELL AND ON (B)(6) 2026, THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. THE PATIENT HAD SIGNS AND SYMPTOMS OF LOW-PRESSURE HYDROCEPHALUS, SWELLING OF HIS PSEUDOMENINGOCELE AFTER IT HAD BEEN FLAT, CONFUSION, AND IMBALANCE. SYMPTOMS LASTED FOR 3 DAYS BEFORE ARRIVING TO THE EMERGENCY ROOM (ER). THE SHUNT WAS CHECKED AND WAS AT SETTING 8, SO THEY REPROGRAMMED IT TO 4. THE SYMPTOMS DID NOT IMPROVE. X-RAY THE NEXT DAY SHOWED IT BACK AT 8. THE PHYSICIAN COMMENTED THAT THE NURSE PRACTITIONER (NP) MAY NOT HAVE PROGRAMMED IT SUCCESSFULLY, BUT MAYBE IT CHANGED BACK TO AN 8 AGAIN. ON (B)(6) 2026, THE PATIENT WAS REPROGRAMMED TO A 4. STILL, THE PATIENT¿S SYMPTOMS DID NOT IMPROVE. THEREFORE, THE VALVE WAS REMOVED ON (B)(6) 2026. BEFORE THE PROCEDURE, THE PHYSICIAN USED THE MANUAL PROGRAMMER TO SET IT AT SETTING 4. THE SURGEON CUT THE DISTAL CATHETER, AND THE VALVE DID NOT HAVE ANY CEREBROSPINAL FLUID (CSF) FLOW. A NEW CER
Patient problems: Ambulation or Postural Difficulties; Confusion/ Disorientation
MAUDE report 24469560 ↗InjuryFeb 13, 2026Crack
InjuryJan 7, 2026Failure to Align
InjuryDec 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryDec 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A FACILITY REPORTED THE SIPHONGUARD OF A CERTAS VALVE (ID 828814PL) DETACHED/FRACTURED AFTER IMPLANTATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 23832417 ↗MalfunctionDec 12, 2025Failure to Align; Failure to Align
Other Integra LifeSciences Switzerland Sàrl products
All Integra LifeSciences Switzerland Sàrl devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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