ThermoCool SF NAV BNI35BFCTRecalls & reported problems
Biosense Webster Inc · Class 3
All models of ThermoCool SF NAV (17)
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 10846835003161), received between Mar 23, 2019 and Mar 23, 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.
InjuryMar 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, AFTER AFIB WAS COMPLETED AND WERE BURNING AT CAVOTRICUSPID LINE (CTI), THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE) CATHETER. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION PURPOSES. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PATIENT¿S OUTCOME WAS IMPROVED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK TRANSSEPTAL NEEDLE. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. RECOMMENDED FLOW SETTINGS FOR THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER THAT WAS USED 8-15 ML/MIN DEPENDING ON THE WATTAGE APPLIED. THE BIOSENSE WEBSTER
Patient problems: Cardiac Tamponade
MAUDE report 8446645 ↗
Other catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices
- QDOT MICRO D139505Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter27 deaths915 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR96200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths269 reports
- QDOT MICRO D139504Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter7 deaths138 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 recall5 deaths77 reports
- QDOT MICRO D139401Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths114 reports
- NaviStar ThermoCool NI75TCDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter111 reports
- NaviStar RMT ThermoCool NR7TCSIYBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter9 deaths103 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR9620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter78 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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