ThermoCool SF BDI35FJRTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846835002843), received between Dec 15, 2016 and Aug 20, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SF CATHETER AND A STERILIZATION COMPROMISED ISSUE OCCURRED. DURING NODAL ABLATION, THE PACKAGING OF THE THERMOCOOL SF CATHETER WAS PHYSICALLY BROKEN AND THE CATHETER WAS NOT IN STERILE CONDITION. THEY HAD TO OPEN A NEW CATHETER. THE EVENT OCCURRED DURING STERILE PROCESSING AND DURING FIELD INSPECTION. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 29-JUL-2024. THERE WAS PHYSICAL DAMAGE TO THE PACKAGING. THE DEVICE WAS SECURED PROPERLY IN THE TRAY. THERE WAS NO DAMAGE TO THE DEVICE DUE TO ANY PART OF THE PACKAGING BEING DAMAGED. THE CALLER DOES NOT HAVE THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 31-JUL-2024. IT WAS CONFIRMED THAT THE CATHETER WAS NOT USED ON THE PATIENT. THE PACKAGING DAMAGE ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE STERILIZATION COMPROMISED ISSUE WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005620 ↗
• InjuryApr 8, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A CLINICAL TRIAL, IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF BI-DIRECTIONAL CATHETER ON (B)(6) 2022. THE PATIENT SUFFERED A DEEP VEIN THROMBOSIS ON (B)(6) 2022 REQUIRING PROLONGED HOSPITALIZATION. ON (B)(6) 2022 DEEP VEIN THROMBOSIS OCCURRED. PER THE STUDY INVESTIGATOR THE SEVERITY OF THE EVENT WAS MILD AND CONSIDERED SERIOUS. THE PATIENT DID SUFFER A SERIOUS DETERIORATION IN HEALTH. THE EVENT WAS NOT LIFE-THREATENING ILLNESS OR INJURY AND THERE WAS NO PERMANENT IMPAIRMENT. THE PATIENT DID REQUIRE PROLONGATION HOSPITALIZATION FROM (B)(6) 2022 TO (B)(6) 2022. MEDICAL OR SURGICAL INTERVENTION WAS NOT NECESSARY TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT. THE PATIENT DID RECEIVE AN UNKNOWN MEDICATION. THE OUTCOME IS RECOVERING/RESOLVING. CARDIOVERSION, RE-ABLATION, SURGERY OR OTHER INTERVENTION WERE NOT REQUIRED. PER THE STUDY INVESTIGATOR THE RELATIONSHIP TO STUDY DEVICE WAS NOT RELATED BUT THE RELATIONSHIP TO STUDY PROCEDURE WAS A CAUSAL RELATIONSHIP.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14049436 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT ((B)(6) LB) UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A THERMOCOOL® SF BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) VENTRICULAR FIBRILLATION AND CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)). DURING THE PROCEDURE WHILE ABLATING AT 50 WATTS IN THE LEFT VENTRICLE (LV) THE PHYSICIAN PERFORMED A PACING PROTOCOL, THE PATIENT WAS HEMODYNAMICALLY STABLE; HOWEVER, IT WAS NOTICED THAT THE PATIENT¿S HEART RHYTHM CHANGED TO VENTRICULAR TACHYCARDIA (VT), AND THEN DEGRADED INTO VENTRICULAR FIBRILLATION (VFIB). CARDIOPULMONARY RESUSCITATION PROTOCOLS WERE PERFORMED BY THE MEDICAL STAFF FOR ABOUT 3-4 MINUTES UNTIL THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ABLE TO RESTORE THE RHYTHM AND START PACING. THERE WAS A SLOW RISE IN THE IMPEDANCE WHEN THE PHYSICIAN WAS ABLATING IN THE RIGHT VENTRICLE (RV) BUT THERE WAS NO HIGH FORCE VALUES OR DRASTIC IMPEDANCE CHANGES THROUGHOUT THE PROCEDURE. THE PHYSICIAN CONFIRMED THE PRESENCE OF PERICARDIAL EFFUSION AND A SUSPECTED PERFORATION TO THE RV OR LV APEX. CARDIAC TAMPONADE WAS CONFIRMED BY SOUNDSTAR CATHE

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Ventricular Fibrillation

  MAUDE report 10248704 ↗
• MalfunctionNov 8, 2017Device Contamination with Chemical or Other Material; Impedance Problem; Device Contamination with Chemical or Other Material; Impedance Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR ATRIAL FLUTTER WITH AN EZ STEER THERMOCOOL SF NON-NAVIGATIONAL CATHETER WHERE FOREIGN MATTER WAS FOUND ON THE CATHETER TIP. DURING THE PROCEDURE, ERRATIC IMPEDANCE VALUES WERE NOTED, PROMPTING THE PHYSICIAN TO CHECK THE CATHETER TIP. THE CATHETER WAS REMOVED FROM THE SHEATH, AND A LONG PIECE OF FOREIGN MATERIAL WAS OBSERVED ATTACHED TO THE TIP. THE PHYSICIAN ATTEMPTED TO REMOVE IT BY PULLING, BUT WAS UNABLE TO DO SO. FOR THIS REASON, THE PHYSICIAN BELIEVES THAT THE FOREIGN MATERIAL WAS PART OF THE CATHETER ITSELF. THE CATHETER WAS REPLACED, AND THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED. NO WIRES WERE EXPOSED. THE DEFLECTION KNOB WAS STILL OPERABLE. NO DIFFICULTY WAS NOTED DURING THE REMOVAL OF THE CATHETER FROM THE SHEATH. A ST. JUDE MEDICAL SL3 8FR SHEATH WAS IN USE. FOREIGN MATERIAL ON THE USABLE LENGTH OF THE CATHETER PRESENTS A POSSIBLE RISK TO THE PATIENT, MAKING THIS EVENT MDR REPORTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7010461 ↗
• MalfunctionDec 15, 2016Split; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA WITH A C3 EZ STEER THERMOCOOL NON-NAV SF CATHETER WHERE THE CATHETER PARTIALLY SPLIT OPEN AT THE SHAFT/TIP JUNCTION. THE DAMAGE RESULTED IN INTERNAL WIRES/BRAIDING BEING EXPOSED, BUT DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. NO DIFFICULTY WAS ENCOUNTERED WHILE INSERTING OR REMOVING THE CATHETER FROM THE PATIENT. THE SHEATH IN USE AT THE TIME OF THE EVENT IS UNKNOWN. THE CATHETER WAS REPLACED WITH A DIFFERENT ONE, AND THE CASE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. EXPOSURE TO THE INTERNAL COMPONENTS OF THE CATHETER CREATES A CRITICAL RISK OF THROMBUS TO THE PATIENT, AS DOES THE RISK OF COMPLETE SEPARATION OF THE CATHETER TIP. AS A RESULT, THIS EVENT IS MDR REPORTABLE. THE AWARENESS DATE FOR THIS COMPLAINT IS 12/7/2016, AS THAT IS WHEN A RESPONSE WAS RECEIVED FROM A BWI REPRESENTATIVE WITH INFORMATION MAKING THIS EVENT REPORTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6177457 ↗