WEBSTER F6QF002RTRecalls & 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 10846835007961), received between Jun 30, 2019 and Jun 30, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Tamponade1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT ((B)(6)) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER AND A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER THE CASE WAS OVER, AND THEY WERE PREPARING TO PULL THE SHEATHS THE PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHO (TEE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 250CC OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THE PATIENT STAYED AN EXTRA DAY FOR OBSERVATION PURPOSES. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED, PHYSICIAN BELIEVES THE ISSUE WAS CAUSED BY WEBSTER RV CATHETER MANIPULATION NEAR THE END OF THE PROCEDURE, (AFTER THE ABLATION PART OF THE PROCEDURE WAS OVER) DUE TO NON-CAPTURE AND FELT THAT THE REPOSITIONING OF THE RV CATHETER RESULTED IN THE INJURY. HE MENTIONED THAT HE THINKS THIS CATHETER IS STIFFER THAN SOME OTHERS, AND THAT THE PATIENT¿S ANATOMY (THINNER VENTRICLE) MIGHT HAVE ALSO CONTRIBUTED TO THE ADVERSE EVEN
Patient problems: Cardiac Tamponade
MAUDE report 8746943 ↗
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- 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.
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