WEBSTER F5QD005RTRecalls & reported problems
Biosense Webster Inc · Class 2
All models of WEBSTER (29)
Data updated Oct 16, 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 10846835007244), received between Nov 30, 2017 and Nov 30, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Entrapment of Device1
Patient problems
- Arrhythmia1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2017Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A CRYOBALLOON ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WITH WEBSTER CATHETERS X 2 AND SUFFERED A MEDICAL DEVICE ENTRAPMENT (REQUIRING SURGICAL INTERVENTION) AND HEART BLOCK. FAST ANATOMICAL MAPPING (FAM) WAS PERFORMED WITH THE NAVISTAR CATHETER. THE CORONARY SINUS CATHETER WAS POSITIONED IN THE CORONARY SINUS UNDER FAM AND CARTO-UNIVU GUIDANCE TO REDUCE RADIATION EXPOSURE. WEBSTER CATHETER # 1 WAS ADVANCED THROUGH THE INFERIOR VENA CAVA (IVC). WHILE CROSSING THE TRICUSPID ANNULUS, WEBSTER CATHETER # 1 BECAME ENTRAPPED. ATTEMPTS TO FREE THE CATHETER VIA MANUAL MANEUVERS WERE UNSUCCESSFUL. THE PROXIMAL END (CONNECTOR SIDE) OF WEBSTER CATHETER # 1 WAS CUT OFF. A 7 FRENCH GUIDING CATHETER (BRAND-UNSPECIFIED) WAS ADVANCED OVER WEBSTER CATHETER # 1. WEBSTER CATHETER # 1 AND THE 7 FRENCH GUIDING CATHETER WERE REMOVED FROM THE PATIENT¿S BODY. WEBSTER CATHETER # 2 WAS INSERTED, POSITIONED IN THE RIGHT VENTRICLE (RV), AND THE PROCEDURE CONTINUED. THERE WERE NO INJURIES AS A RESULT OF THE MEDICAL DEVICE ENTRAPMENT. IT WAS NOTED THAT THERE WAS A 2-HOUR DELAY IN THE PROCEDURE. LATER IN THE PROCEDURE, IT WAS DETERMINED THAT
Patient problems: Arrhythmia; No Code Available
MAUDE report 7073132 ↗
Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices
- Advisor™ HD Grid, Sensor Enabled™ D-AVHD-DF16St. Jude Medical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING6 deaths358 reports
- IntellaMap Orion™ M004RC64S0Boston Scientific Corporation · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING6 deaths356 reports
- ACHIEVE™ 990063-020Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING7 deaths129 reports
- Inquiry™ IBI-81104Irvine Biomedical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 recall2 deaths64 reports
- DECANAV R7F282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 deaths108 reports
- LASSO NAV D134301Biosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 deaths82 reports
- DECANAV R7D282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death75 reports
- ACHIEVE ADVANCE™ 2ACH20Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 deaths69 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page