WEBSTER F6QA005RTRecalls & reported problems
Biosense Webster Inc · Class 2
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 10846835000481), received between Dec 12, 2025 and Dec 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction 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
- Patient Device Interaction Problem1
Patient problems
- Cardiac Arrest1
- Ventricular Fibrillation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
DURING CARDIAC ABLATION PROCEDURE WITH A WEBSTER QUAD CATHETER, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) TREATED WITH CHEST COMPRESSIONS AND DEFIBRILLATION ABOUT 5-6 TIMES. THE LAST KNOWN STATUS OF THE PATIENT WAS THAT THEIR BLOOD PRESSURE WAS NORMAL, THEY WERE IN SINUS RHYTHM, AND A STAT ECHO WAS ORDERED. IT WAS REPORTED THAT WHILE STEMMING THE VENTRICLE TO SEE THE SEVERITY OF THE PATIENT'S VT (VENTRICULAR TACHYCARDIA), IT STARTED IN VT AND DETERIORATED INTO VF. THE PATIENT¿S BLOOD PRESSURE PLUMMETED, AND THE MEDICAL TEAM HAD TO CALL A CODE. THE PATIENT WAS ALREADY INTUBATED WHEN THEY NOTICED THE DROP IN BLOOD PRESSURE. THEY NOTICED THIS DUE TO THE 12LEAD BEING ALL VF AND WAS CONFIRMED ON X-RAY AND WITH THE QUAD CATHETER THAT WAS IN THE RIGHT VENTRICLE. THE ONLY KNOWN MEDICAL INTERVENTION PROVIDED TO THE PATIENT WERE CHEST COMPRESSIONS AND DEFIBRILLATION ABOUT 5-6 TIMES. THE ONLY BWI IN USE AT THE TIME WAS A QUAD CATHETER (FIX 6F,4P,A,SD,5MM,10PN-DR,115), CARTO 3 SYSTEM, AND PATCHES ON THE PATIENT. NO GENERATOR WAS IN USE, AND THE CASE WAS ABORTED. THE INFORMATION RECEIVED INDICATED THAT THE INTERVENTION PROVIDED WAS ANESTHESIA PROTOCOL. THE OUTCOME OF THE ADVERSE EVE
Patient problems: Cardiac Arrest; Ventricular Fibrillation
MAUDE report 23796296 ↗
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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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