CODMAN® HOLTER® 821654Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HOLTER® Ventricular Catheter 4cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10381780517900), received between Feb 21, 2025 and Feb 21, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
- Migration1
Patient problems
- Fatigue1
- Headache1
- Vomiting1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2025Material Separation; Migration; Material Separation; Migration
A FACILITY REPORTED A VENTRICULAR CATHETER (ID 821654) WAS IMPLANTED ON (B)(6) 2024. THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SYMPTOMS OF INTRACRANIAL HYPERTENSION (VOMITING, FATIGUE AND HEADACHES). A BRAIN SCAN WAS PERFORMED URGENTLY, SHOWING THE DISCONNECTION OF THE PROXIMAL CATHETER FROM THE VALVE AND ITS MIGRATION INTO THE INTRAPARENCHYMAL TOWARDS THE BRAINSTEM. THEREFORE, THE PROXIMAL CATHETER WAS REMOVED AND REPLACED. ALL PIECES WERE RECOVERED, AND INTRAVENTRICULAR BLEEDING WAS REPORTED.
Patient problems: Fatigue; Headache; Vomiting
MAUDE report 21432799 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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