ThermoCool SF NAV BNI35BBHRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846835003130), received between Jul 14, 2016 and Dec 5, 2025 — classified as 5 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CATHETER ABLATION PROCEDURE WAS PERFORMED WITH A THERMOCOOL SF NAV CATHETER TO TREAT PREMATURE VENTRICULAR CONTRACTION AND NON-SUSTAINED VENTRICULAR TACHYCARDIA, THE PATIENT EXPERIENCED PREMATURE VENTRICULAR CONTRACTION RECURRENCE, AND THE CATHETER ABLATION WAS PERFORMED AGAIN. CORONARY VENOGRAPHY REVEALED OCCLUSION IN A PART OF A CORONARY VEIN. DURING THE PROCEDURE ITSELF, THE RIGHT VENTRICULAR OUTFLOW TRACT, LEFT VENTRICULAR OUTFLOW TRACT, AND AREAS NEAR THE CORONARY VEINS WERE ABLATED, AND A TEMPORARY SUPPRESSIVE EFFECT WAS OBSERVED. AFTER THE PROCEDURE (UNKNOWN DATE), PREMATURE VENTRICULAR CONTRACTION RECURRED, AND THE CATHETER ABLATION WAS PERFORMED AGAIN. CORONARY VENOGRAPHY REVEALED OCCLUSION IN A PART OF A CORONARY VEIN. ALTHOUGH THERE WERE NO CLINICAL SYMPTOMS FROM THE OCCLUSION, ABLATION AT THE TARGET SITE WAS DIFFICULT, SO THE PROCEDURE WAS DISCONTINUED. DEFINITIVE CURE FOR PREMATURE VENTRICULAR CONTRACTION WAS NOT ACHIEVED. THE PHYSICIAN'S COMMENT WAS THAT REGARDING THE RECURRENCE, SINCE ACCESS TO THE EARLIEST EXCITATION SITE WITH THE CATHETER WAS DIFFICULT, THE ABLATION HAD TO BE PERFORMED AT A PROXIMAL SITE. IT MAY HAVE CONTRIBUTED TO AN INSUF

  Patient problems: Perforation of Vessels

  MAUDE report 23730088 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH AN THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING THE PROCEDURE, PVI WAS SUCCESSFULLY PERFORMED WITHOUT ANY ISSUES REPORTED. AS PART AS THEIR NORMAL PROCESS, A TRANSTHORACIC ECHO (TEE) WAS PERFORMED WHILE THE PATIENT WAS ON THE TABLE SHOWING NO ISSUES. PRAXBIND WAS ADMINISTERED TO REVERSE ANTI-COAGULANT (PRADAXA). THE PATIENT WAS EXTUBATED AND THEN MOVED TO HIS BED. POST PROCEDURE, AFTER 20-30 MINUTES IN RECOVERY, THE PATIENT WAS REPORTED TO BE HIGHLY-HYPOTENSIVE. TRANSTHORACIC ECHO WAS PERFORMED AGAIN, AND CARDIAC TAMPONADE WAS CONFIRMED. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) WHERE A PERICARDIOCENTESIS WAS PERFORMED TO REMOVE THE FLUID FROM THE PERICARDIUM. PERICARDIAL DRAINAGE WAS NOT SUCCESSFUL, AND THE PATIENT REQUIRED A THORACOTOMY. THE PATIENT CONDITION IMPROVED AND WAS REPORTED TO BE IN STABLE CONDITION AFTER SURGERY. EXTENDED HOSPITALIZATION OF 4-5 DAYS WAS REQUIRED FOR MONITORING. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPI

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 8003217 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. LEFT ATRIAL GEOMETRY WAS PERFORMED. AFTER APPROXIMATELY 5 MINUTES OF ABLATION, A PERICARDIAL EFFUSION WAS DETECTED. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. HEMOSTASIS WAS ACHIEVED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT REQUIRED 1 ADDITIONAL DAY OF HOSPITALIZATION FOR MONITORING. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PROCEDURE OR PATIENT CONDITION. IT IS UNKNOWN AT WHAT POINT DURING THE PROCEDURE THE INJURY OCCURRED. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A COOK MEDICAL TRANSSEPTAL NEEDLE AND AN AGILIS 8 FRENCH 71 CM SHEATH. THERE IS NO INFORMATION REGARDING GENERATOR PARAMETERS, GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, LAST ABLATION CYCLE TIME AT THE SITE OF INJURY, OR IRR

  Patient problems: Cardiac Tamponade

  MAUDE report 7509246 ↗
• InjuryJul 31, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A REDO PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE UNDER GENERAL ANESTHESIA FOR ATRIAL FIBRILLATION AND ATRIAL ECTOPY WITH AN THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A PERICARDIAL EFFUSION REQUIRING EXTENDED HOSPITALIZATION. CORONARY SINUS (CS) CATHETER WAS PLACED IN THE CS, TRANSSEPTAL PUNCTURE WAS PERFORMED, AND THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER WAS POSITIONED IN THE RIGHT ATRIUM FOR MAPPING. A X-RAY REVEALED CONTRAST MEDIUM IN THE PERICARDIAL SPACE. PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT REMAINED IN THE CATHETERIZATION LAB UNDER GENERAL ANESTHESIA WHILE THE PHYSICIAN EVALUATED THE SEVERITY OF THE EFFUSION/PERFORATION. AFTER APPROXIMATELY 45-60 MINUTES, THE PATIENT EMERGED FROM ANESTHESIA AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR MONITORING. PATIENT WAS UNDER GENERAL ANESTHESIA FOR 90 MINUTES. PATIENT REQUIRED ONE DAY OF EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR MONITORING. PATIENT HAS SINCE FULLY RECOVERED. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE A NARROW ANATOMICAL WINDOW

  Patient problems: Pericardial Effusion

  MAUDE report 6753706 ↗
• InjuryJul 14, 2016Use of Device Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION AND AN ELECTROPHYSIOLOGY STUDY WITH RADIOFREQUENCY ABLATION FOR ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) WITH A THERMOCOOLSF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A VESSEL PERFORATION REQUIRING NON-SURGICAL DRAINAGE. DURING THE TRANSSEPTAL PUNCTURE, A VESSEL PERFORATION WAS SUSPECTED. AORTIC PERFORATION WAS CONFIRMED VIA FLUOROSCOPY. BLOOD WAS DRAINED VIA A NON-SURGICAL APPROACH. REMAINDER OF PROCEDURE WAS CANCELLED, NO ABLATION HAD BEEN PERFORMED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION THROUGHOUT THE PROCEDURE. PATIENT WAS TRANSFERRED BACK TO THE WARD. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. PATIENT HAS FULLY RECOVERED. PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. THERE WERE NO COMPLAINTS OF FAILURE WITH THE CARTO 3 SYSTEM. IT WAS NOTED THAT NO CATHETER WAS BELIEVED TO HAVE CAUSED THE ADVERSE EVENT, AS NO CATHETER WAS INVOLVED WITH TRANSSEPTAL PUNCTURE. HOWEVER, BIOSENSE WEBSTER CATHETERS WERE IN PLACE AT THE TIME THE INJURY WAS DISCOVERED, THEREFORE THIS EVENT IS BEING CONSER

  Patient problems: Atrial Perforation; Perforation of Vessels

  MAUDE report 5794477 ↗