WEBSTER D1085413Recalls & reported problems
Biosense Webster Inc · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835010114), received between Aug 14, 2024 and Aug 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
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.
MalfunctionAug 14, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH A WEBSTER CATHETER. THERE WAS A HAIR PRESENT INSIDE OF THE STERILE PACKAGING OF THE WEBSTER CATHETER. THE WEBSTER CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTICED BEFORE USE AND THEREFORE, NOT USED ON THE PATIENT. IF THEY HAVE NOT ALREADY, THEY WILL SHIP BACK ALL THE MATERIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19982702 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.