CODMAN® CERTAS® 828815PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with SIPHONGUARD® and Accessories · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780535966), received between May 29, 2026 and May 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Align” (1 report).
1 other recall cover devices cleared under the same FDA submission (K223330); they may or may not involve this specific model.
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
- Failure to Align1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223330. One submission often covers many models, so check the product and lot details in each record.
- Z-0978-2025 · Dec 16, 2024 · Open, ClassifiedCODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.