ThermoCool SF BDI35DFRTRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10846835002812), received between Sep 5, 2017 and Dec 6, 2024 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Obstruction of Flow; High Readings; Obstruction of Flow; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SF AND DURING THE CASE, WHILE USING THE CATHETER, IMPEDANCE WENT ABOVE 200 AND ABLATION STOPPED. THEY RECONNECTED THE CABLE, CHECKED IF THE IMPEDANCE PATCH WAS ON THE RIGHT POSITION ATTACHED TO THE PATIENT, AND PULLED OUT THE CATHETER TO CHECK IF THERE WAS ANY ISSUE RELATED TO IRRIGATION. THEY FOUND OUT THAT IRRIGATION HOLE WAS STUCK AND COULD NOT BE FLUSHED. WHEN THEY CHANGED THE CATHETER, THE ISSUE WAS RESOLVED. IT WAS FOUND OUT TO BE A CATHETER ISSUE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860625 ↗
• InjuryDec 30, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SF BI-DIRECTIONAL CATHETER AND THE PATIENT HAD THROMBOSIS AND CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. IT WAS REPORTED THAT TAMPONADE OCCURRED IN A PROCEDURE WITH PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) WHICH HAD BEEN CONVENTIONALLY PERFORMED SINCE AROUND 19:00 ON DEC. 6. ALTHOUGH DRAINAGE WAS CONDUCTED, THE CONDITION DID NOT IMPROVE, AND THROMBUS WAS PULLED IN. BECAUSE THE SITE OF BLEEDING WAS UNKNOWN, SURGERY FOR HEART-LUNG MACHINE PLACEMENT BY MIDLINE INCISION WAS PERFORMED. AFTER OPERATION FROM AROUND 11:00 ON DEC. 6 TO AROUND 5:00 ON THE FOLLOWING DAY, THE PATIENT IS CURRENTLY BEING FOLLOWED UP IN INTENSIVE CARE UNIT (ICU). THORACOTOMY WAS PERFORMED. BLOOD WAS OBSERVED IN THE LEFT VENTRICULAR POSTERIOR WALL, AND TREATMENT WITH HEMOSTAT WAS PERFORMED. BLEEDING WAS NOT FROM A SINGLE POINT, BUT A FINDING THAT SLOWLY BLEEDS FROM THE ENTIRE AREA. ADDITIONAL INFORMATION RECEIVED INDICATED EXTUBATION WAS SCHEDULED TO BE PERFORMED (B)(6) 2021. ALTHOUGH RENAL FUNCTION DECREASED WAS NOTED, IT WAS CONFIRMED BY CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT) THAT HEM

  Patient problems: Cardiac Tamponade; Thrombosis/Thrombus

  MAUDE report 13122270 ↗
• MalfunctionNov 9, 2021Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A THERMOCOOL® SF BI-DIRECTIONAL CATHETER. THE TIP WAS BROKEN. THE TIP OF THE CATHETER WAS BROKEN ON INTRA-OP. IT'S NORMAL THAT THE CATHETER HAS BI-DIRECTIONAL CURVES (D/F), BUT ONE OF THE CURVES WAS BROKEN DURING THE PROCEDURE, SO THE PHYSICIAN COULD NOT MANIPULATE THE CATHETER PROPERLY. THE PHYSICIAN REQUESTED TO CHANGE THE CATHETER. THE CATHETER WAS REPLACED WITH NEW ONE, AND IT HAS CURVED WELL WITHOUT ANY CURVE PROBLEM. AFTER USING NEW CATHETER, THE PROCEDURE HAS SUCCESSFULLY DONE. NO WIRE WAS EXPOSED AND NO LIFTING OR SHARP RINGS OCCURRED. THERE WAS NO REPORTED RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. IT WAS NOT A PRE-SHAPED. SHEATH WAS AN AGILIS, 8.5F. DEFLECTION ISSUE IS NOT MDR-REPORTABLE. BROKEN TIP IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12777047 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH AN THERMOCOOL® SF BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE WHEN ABLATING AT THE ROOF LINE, CARDIAC TAMPONADE WAS CONFIRMED. 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. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED. PATIENT¿S OUTCOME WAS IMPROVED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION-RELATED. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME.

  Patient problems: Cardiac Tamponade

  MAUDE report 8435753 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACCESSORY PATHWAY ABLATION PROCEDURE WITH AN EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THERMOCOOL® SF BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE. DURING THE ACCESSORY PATHWAY PROCEDURE, A CARDIAC TAMPONADE WAS DETECTED. THERE IS NO INFORMATION REGARDING INTERVENTIONS, EXTENDED HOSPITALIZATION, PATIENT OUTCOME, FACTORS THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT, OR THE PHYSICIAN¿S CAUSALITY OPINION. THERE WERE NO ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING TRANSSEPTAL PUNCTURE, SHEATH, GENERATOR PARAMETERS, GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, LAST ABLATION CYCLE TIME AT THE SITE OF INJURY, IRRIGATED CATHETER FLOW RATE, OR ANTICOAGULATION DURING THE PROCEDURE. THIS WAS NOT A CARTO SYSTEM CASE, AS THE CATHETERS WERE NON-NAVIGATIONAL.

  Patient problems: Cardiac Tamponade

  MAUDE report 7442337 ↗
• DeathMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FLUTTER WITH A THERMOCOOL® SF BI-DIRECTIONAL CATHETER AND SUFFERED A CEREBROVASCULAR ACCIDENT (REQUIRING ANESTHETIZATION) AND DEATH. DURING THE PROCEDURE, AFTER THE ADMINISTRATION OF RYTMONORM (RHYTHMOL, PROPAFENONE), THE PATIENT ENTERED INTO A PSYCHOTIC STATE. AN UNSPECIFIED SEDATIVE WAS ADMINISTERED. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). PATIENT REQUIRED EXTENDED HOSPITALIZATION (4 DAYS) AS A RESULT OF THE ADVERSE EVENT. WHILE IN THE ICU, A CEREBRAL HEMORRHAGE WAS DETECTED. PATIENT WAS ANESTHETIZED. PATIENT DID NOT REGAIN CONSCIOUSNESS AND EXPIRED. IT WAS LATER CONFIRMED THAT THE CEREBRAL HEMORRHAGE OCCURRED DURING THE ATRIAL FLUTTER PROCEDURE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PROCEDURE AND PATIENT CONDITION. IT WAS NOTED THAT THE ADVERSE EVENT (CEREBROVASCULAR ACCIDENT) WAS ATTRIBUTED TO MEDICATIONS USED DURING THE PROCEDURE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF DEATH WAS THAT IT WAS SECONDARY TO THE CEREBRAL HEMORRHAGE. SINCE THE ADVERSE EVENT RESULTED IN THE PATIENT¿S DEATH, IT IS MDR REPORTABLE.

  Patient problems: Death; Stroke/CVA

  MAUDE report 7386411 ↗
• MalfunctionNov 7, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SF BI-DIRECTIONAL CATHETER AND FOREIGN MATERIAL (A PIECE OF PLASTIC) WAS DISCOVERED ON THE CATHETER TIP BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT, HOWEVER NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS EVENT IS MDR REPORTABLE BECAUSE FOREIGN MATERIAL FOUND ADHERED WITHIN THE USABLE LENGTH OF THE CATHETER DURING OR AFTER THE PROCEDURE, POSE A POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7006651 ↗
• InjurySep 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA/RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL SF NON-NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) AND ELECTROCARDIOGRAM ST SEGMENT ELEVATION (WITH NO INTERVENTIONS REPORTED). MAPPING WAS PERFORMED WITH A BOSTON SCIENTIFIC INTELLAMAP ORION MAPPING CATHETER. ABLATION WAS PERFORMED ON THE RVOT AND THE OPPOSITE SIDE OF THE LEFT VENTRICLE (UNSPECIFIED). PVC MORPHOLOGY WAS MODIFIED BY ABLATION. MAPPING AND ABLATION WERE REPEATED. PATIENT BECAME HYPOTENSIVE AND THE ST SEGMENT BECAME ELEVATED. PERICARDIAL EFFUSION WAS CONFIRMED VIA ECHOCARDIOGRAPHY. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED AMOUNT OF FLUID. PATIENT RECOVERED AND WAS REPORTED TO BE IN STABLE CONDITION. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT OUTCOME IS IMPROVED. 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 PROCEDURE-RELATED. PHYSICIAN INDICATED THAT IT IS UNKNOWN WHEN THE ADVERSE EVENT OCCURRED. IT W

  Patient problems: Cardiac Tamponade; ST Segment Elevation

  MAUDE report 6894275 ↗
• InjurySep 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAVOTRICUSPID ISTHMUS (CTI) ABLATION PROCEDURE FOR ATRIAL FLUTTER WITH A C3 EZ STEER THERMOCOOL SF NON-NAVIGATIONAL CATHETER AND SUFFERED A HEART BLOCK AV REQUIRING SURGICAL INTERVENTION (CARDIAC PACEMAKER INSERTION). DURING THE PROCEDURE, AFTER ABLATING THE CTI, A HEART BLOCK OCCURRED. A VVI PACEMAKER (VENTRICLE PACED, VENTRICLE SENSED, INHIBITED IF BEAT IS SENSED) WAS IMPLANTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION ON POST-PROCEDURE DAY 1. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PROCEDURE AND PATIENT CONDITION. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

  Patient problems: Complete Heart Block; No Code Available

  MAUDE report 6843789 ↗