CODMAN® CERTAS® Plus 828827PLRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with SIPHONGUARD®, Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, and Information Manual · 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 10381780535867), received between Feb 27, 2026 and Feb 27, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
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
- Obstruction of Flow1
Patient problems
- Ambulation or Postural Difficulties1
- Confusion/ Disorientation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Other CATHETER, VENTRICULAR devices
- CODMAN® HAKIM® BACTISEAL® NS5524Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR1 recall1 report
- CODMAN® BACTISEAL® NS0339Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR6 reports
- CODMAN® BACTISEAL® NS0340Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR5 reports
- CODMAN® BACTISEAL® NS0338Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR3 reports
- AESCULAP FV077PChristoph Miethke GmbH & Co. KG · CATHETER, VENTRICULAR2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.