CODMAN CERTAS SIPHONGUARD 82-8814PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704081937), received between Feb 16, 2022 and Jul 11, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2023Obstruction of Flow; Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 17301151 ↗
• InjuryFeb 22, 2023Break; Pressure Problem; Break; Pressure Problem

  N/A.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16419214 ↗
• InjuryMay 26, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  A PHYSICIAN REPORTED A CERTAS VALVE (UNKNOWN ID) WAS IMPLANTED IN (B)(6) 2022. THE PATIENT WAS SEEN FOR FOLLOW UP ON (B)(6) 2022; THE VENTRICLES WERE SLIT-LIKE SO THE VALVE SETTING WAS INCREASED FROM 1 TO 3. ON (B)(6) 2022 THE PATIENT WAS SEEN WITH SHUNT MALFUNCTION SYSTEM. THE PATIENT WAS LETHARGIC, VOMITING, NOT EATING, AND NOT SEEMING HIMSELF. IMAGING INCREASED VENTRICLES. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. UPON VP SHUNT REVISION PERFORMED: ON INITIAL INCISION GENERALIZED CSF LEAKAGE WAS NOTED AROUND THE VALVE. EXPLORING VALVE SITE NOTED THAT THE VALVE ITSELF WAS FRACTURED, WITH NOTABLE CSF LEAKING, AND APPEARED TO BE COMPLETELY SHEARED OFF AT SIPHONGUARD AREA OF THE VALVE.

  Patient problems: Lethargy; Vomiting

  MAUDE report 14519063 ↗
• InjuryFeb 16, 2022Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2022 WITH UNKNOWN SETTING. AFTER THE VALVE WAS IMPLANTED THERE WAS NO CHANGE IN THE VENTRICLES. ON (B)(6) 2022 THE SET PRESSURE COULD NOT BE CHANGED FROM SETTING 6 TO 1. ON (B)(6) 2022 ANOTHER ATTEMPT WAS MADE TO CHANGE THE SET PRESSURE USING A NEODYMIUM MAGNET, BUT THE PRESSURE COULD NOT BE CHANGED EITHER. AFTER ADDING A CONTRAST MEDIUM AND CONFIRMING PATENCY, VALVE OBSTRUCTION WAS CONFIRMED. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13543067 ↗