CODMAN HOLTER 82-1676Recalls & reported problems
Cerenovus, Inc. · CODMAN HOLTER Atrial Catheter Type "E" · 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 10886704040675), received between Feb 6, 2025 and Feb 6, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2025Break; Break
1 OF 2 REPORTS (SAME FAILURE/DIFFERENT PATIENTS). OTHER MFG REPORT NUMBER: 3013886523-2025-00029. A FACILITY REPORTED THE TAPERED PART OF THE CATHETER (ID 821676) BROKE OFF FROM THE WIDER PART A FEW MONTHS AFTER IMPLANTATION. AN INTERVENTION OF A VASCULAR SURGEON WAS NECESSARY TO REMOVE THE BROKEN PART FROM THE PATIENT'S ATRIUM. THE EVENT HAPPENED IN TWO PATIENTS.
Patient problems: Insufficient Information
MAUDE report 21323526 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.