CODMAN CERTASRecalls & reported problems across all models
Integra LifeSciences Switzerland Sàrl · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one CODMAN CERTAS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 1
We found 8 models of CODMAN CERTAS by Integra LifeSciences Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Dec 30, 2024 and May 29, 2026 — classified as 11 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
CODMAN CERTAS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 16, 2024Class IIOpen, Classified
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0978-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported CODMAN CERTAS problems
Device problems
- Insufficient Device Problem Information4
- Obstruction of Flow3
- Break2
- Failure to Align2
- No Flow2
- Detachment of Device or Device Component1
- Failure to Prime1
- Output Problem1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions6
- Headache1
- Sleep Dysfunction1
- Vomiting1
CODMAN CERTAS models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CODMAN® CERTAS® 828810PLShunt, central nervous system and components1 recall2 reports
- CODMAN® CERTAS® 828804PLShunt, central nervous system and components5 reports
- CODMAN® CERTAS® 828814PLShunt, central nervous system and components4 reports
- CODMAN® CERTAS® 828800PLShunt, central nervous system and components2 reports
- CODMAN® CERTAS® 828801PLShunt, central nervous system and components1 report
- CODMAN® CERTAS® 828811PLShunt, central nervous system and components1 report
- CODMAN® CERTAS® 828815PLShunt, central nervous system and components1 report
- CODMAN® CERTAS® 828825PLShunt, central nervous system and components1 report
Recent CODMAN CERTAS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 29, 2026Failure to Align
1 OF 2 REPORTS (SAME EVENT/DIFFERENT PRODUCTS). OTHER MFT REPORT NUMBER: 3014334038-2026-00038. A PHYSICIAN REPORTED A CERTAS VALVE WAS PLACED ON (B)(6) 2025. THE PHYSICIAN EXPERIENCED ISSUES CHECKING THE VALVE SETTING AND PROGRAMMING IT WITH THE ELECTRONIC PROGRAMMER (ID (B)(6)). ON (B)(6) 2026, THEY TRIED TO ADJUST THE VALVE; HOWEVER, THE ELECTRONIC PROGRAMMER DID NOT APPEAR TO CHANGE. THE PHYSICIAN WANTED TO MOVE IT FROM 7 TO 8, BUT IT WOULD NOT MOVE. IT IS POSSIBLE THE VALVE MALFUNCTIONED AND BECAME STUCK AND UNABLE TO PROGRAM. IT IS ALSO POSSIBLE THERE WAS AN ISSUE USING THE ELECTRONIC PROGRAMMER (A MAGNET COULD HAVE BEEN INTERFERING OR SOMETHING ELSE COULD BE WRONG WITH THE PROGRAMMER). THE PLACEMENT OF THE VALVE FOR THIS PATIENT WAS ALSO A LITTLE MORE DIFFICULT SINCE IT WAS MORE BEHIND THE EAR THAN ON THE TOP OF THE HEAD. OUT OF CAUTION AND TO ADDRESS THE PATIENT¿S CONCERN, THE VALVE WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY SPECIFIC SYMPTOMS PRIOR TO REPLACING THE VALVE. THE PATIENT IS DOING WELL. THE PATIENT IS HUMAN IMMUNODEFICIENCY VIRUS (HIV) POSITIVE. THE ELECTRONIC PROGRAMMERS WERE TESTED USING A DEMO SHUNT, AND THEY ALL WORKED WELL. HOWEVER, IT WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330477 ↗InjuryMay 15, 2026Unintended System Motion
InjuryMar 20, 2026Insufficient Device Problem Information
MalfunctionJan 12, 2026Break
InjuryDec 30, 2025Failure to Align; Failure to Align
A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) SETTING WOULD NOT CHANGE. NO PATIENT INJURY REPORTED, HOWEVER, ACCORDING TO INFORMATION PROVIDED, REVISION/MEDICAL INTERVENTION REQUIRED, IT IS UNKNOWN WHAT TYPE OF INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 23931349 ↗InjuryDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A FACILITY REPORTED THE SIPHONGUARD OF A CERTAS VALVE (ID 828804PL) DETACHED IN PATIENT AFTER IMPLANTATION. THEREFORE, THE VALVE WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23782494 ↗MalfunctionOct 31, 2025Obstruction of Flow; Obstruction of Flow
MalfunctionSep 26, 2025Obstruction of Flow; Obstruction of Flow
InjurySep 19, 2025Obstruction of Flow; Obstruction of Flow
InjuryAug 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryAug 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryAug 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJul 25, 2025Break; Break
A FACILITY REPORTED A CERTAS VALVE (ID 828814PL) WAS IMPLANTED ON (B)(6) 2025. AFTER A WEEK, THE PATIENT RETURNED FOR A CHECK-UP WITH SYMPTOMS OF HEADACHE, IRRITABILITY, INABILITY TO SLEEP, AND VOMITING. IT WAS OBSERVED THAT THE VALVE APPEARED TO BE BROKEN IN THE PATIENT¿S CRANIAL AREA. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2025. THE PATIENT DID NOT EXPERIENCE A FALL OR ANY HEAD TRAUMA. THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE. ADDITIONAL INFORMATION: "THE VALVE ANTISIPHON DEVICE SNAPPED IN THE PATIENT WHICH IS WHAT CAUSED IT TO BE EXPLANTED. NOTHING WRONG WITH THE BACTISEAL CATHETER."
Patient problems: Headache; Sleep Dysfunction; Vomiting
MAUDE report 22608550 ↗InjuryJun 6, 2025Output Problem; Output Problem
A PHYSICIAN REPORTED A CERTAS VALVE (ID 828811PL) WAS IMPLANTED ON (B)(6) 2016, WITH A SETTING 4. ON (B)(6) 2017, THE PATIENT SETTING WAS SET TO 5. THE PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) ON (B)(6) 2023 AND WAS SET AT 5. ON (B)(6) 2025, THE PATIENT HAD A CRANIAL MRI FOR A 2-YEAR FOLLOW-UP. HOWEVER, THE SHUNT WAS MOVED AND SET AT 8. THEY WERE UNABLE TO SET THE VALVE TO 5. THEREFORE, A REPROGRAMMING WAS DONE UNDER FLUOROSCOPY, AND THE SHUNT WAS STILL SET TO 8. DUE TO THE ISSUE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2025. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS DUE TO THE PRODUCT ISSUE. THE PATIENT CONDITION IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22159991 ↗MalfunctionJun 6, 2025No Flow; No Flow
2 OF 2 REPORTS (SAME FAILURE, DIFFERENT PATIENTS). OTHER MFG REPORT NUMBER: 3013886523-2025-00131. A FACILITY REPORTED THAT AFTER IMPLANTATION OF A CERTAS VALVE AND AFTER CONNECTING THE DISTAL AND PERITONEAL CATHETERS, THE SURGEON WAS UNABLE TO GET A FLOW TO CONFIRM THE FUNCTION OF THE VALVE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED, HOWEVER, AND THE EVENT LED TO 30 MINUTES SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 22159005 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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