ThermoCool SF NAV BNI35FFCTRecalls & 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 10846835003246), received between Dec 5, 2016 and Dec 5, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Cardiac Tamponade1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2016Insufficient Device Problem Information
IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS AND SURGICAL INTERVENTION. AFTER LEFT PVI (AND PRIOR TO RIGHT PVI), THE AGILIS SHEATH WAS ADVANCED THROUGH THE TRANSSEPTAL PUNCTURE SITE INTO THE LEFT ATRIUM. A FEW MINUTES LATER, THE PATIENT BECAME HYPOTENSIVE. THE CARDIAC TAMPONADE WAS CONFIRMED VIA INTRAVASCULAR ULTRASOUND (IVUS) THROUGH THE AGILIS SHEATH. THE PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF FLUID. REMAINDER OF THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT IN ORDER TO RECOVER FROM THORACIC SURGERY. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. IT WAS NOTED THAT THE ISSUE SEEMED TO BE UNRELATED TO ANY BIOSENSE WEBSTER, INC. PRODUCTS. EVENT OCCURRED 5 MINUTES AFTER THE AGILIS SHEATH W
Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension
MAUDE report 6146518 ↗
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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