ThermoCool SmartTouch D132702Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10846835009170), received between Nov 9, 2016 and Jan 10, 2020 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

8 other recalls cover devices cleared under the same FDA submission (P030031, P040036); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED AN EPICARDIAL EFFUSION REQUIRING A PERICARDIOCENTESIS. BIOSENSE WEBSTER, INC. DOES NOT RECOMMEND THE USE OF ITS DEVICES IN THE EPICARDIAL SPACE. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER, INC. PRODUCTS. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE ISSUE WAS RESOLVED. THE PATIENT¿S CONDITION IS FULLY RECOVERED. THE PATIENT WAS HOSPITALIZED FOR ONE ADDITIONAL DAY. IN THE OPINION OF THE PHYSICIAN, THE EVENT WAS PROCEDURE RELATED. THE TRANSSEPTAL WAS PERFORMED WITH BRK NEEDLE (ABBOTT). PRIOR TO DISCOVERING THE TAMPONADE, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF A STEAM POP. THE IRRIGATION SETTINGS WERE STANDARD FOR SMART TOUCH. GRAPH, DASHBOARD, VECTOR AND VISITAG WERE USED FOR FORCE VISUALIZATION. THERE WERE NO ERROR MESSAGES DISPLAYED BY BIOSENSE WEBSTER, INC. EQUIPMENT. THE VISITAG MODULE WAS USED WITH THE ABLATION INDEX PARAMETERS AND FORCE AS AN ADDITIONAL FILTER. ABLATION INDEX OPTIONS WERE USED FOR COLORING.

  Patient problems: Cardiac Tamponade

  MAUDE report 9576686 ↗
• InjuryMar 13, 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 ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMART TOUCH BIDIRECTIONAL (STSF) CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE NEAR THE END OF THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED SLIGHTLY. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. PERICARDIAL DRAIN WAS LEFT IN PLACE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE EVENT. PATIENT¿S OUTCOME WAS FULLY RECOVERED. PHYSICIAN¿S CAUSALITY OPINION IS UNKNOWN. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN TRANSSEPTAL NEEDLE. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. THE IRRIGATION WAS SET WITHIN STANDARD SETTINGS FOR STSF. THE FORCE VISUALIZATION FEATURES USED INCLUDED GRAPH, DASHBOARD, VECTOR AND VISITAG. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG MODULE WERE 4MM/4SECONDS RESPIRATORY GATED. NO ADDITIONAL FILTER WAS US

  Patient problems: Cardiac Tamponade

  MAUDE report 8418878 ↗
• MalfunctionApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH AN UNSPECIFIED THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE ABLATION WAS STOPPED BY AN ¿IMPEDANCE TO HIGH¿ ERROR MESSAGE. WHEN THE CATHETER WAS REMOVE FROM THE PATIENT¿S BODY, CLOTTING WAS FOUND STUCK TO THE TIP OF THE CATHETER. THE CLOTTING WAS WIPED OFF AND FLUSHING WAS CONDUCTED TO CONTINUE WITH THE PROCEDURE. IT WAS THEN FOUND THAT THE SETTING SELECTION ON THE GENERATOR WAS WRONG, A NON-IRRIGATION SETTING WAS SELECTED IN SPITE OF USING AN IRRIGATION CATHETER. THE PROCEDURE WAS COMPLETED NORMALLY. NO PATIENT CONSEQUENCES WERE REPORTED. THE ISSUE OF IMPEDANCE TO HIGH ERROR MESSAGE IS NOT A REPORTABLE EVENT. HOWEVER, THE CLOT FOUND ATTACHED TO THE TIP OF THE CATHETER IS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7441406 ↗
• InjuryFeb 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PRE-PROCEDURE, A SMALL PERICARDIAL EFFUSION WAS NOTED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). AFTER TRANSSEPTAL PUNCTURE, HEPARIN ADMINISTRATION, AND EXTENSIVE MAPPING, TO INCLUDE DIFFICULT ACCESS TO THE LEFT SUPERIOR PULMONARY VEIN (LSPV), THE PERICARDIAL EFFUSION VOLUME WAS NOTED TO HAVE INCREASED. PERICARDIOCENTESIS WAS PERFORMED AND YIELDED 140 ML OF FLUID. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT REMAINED STABLE THROUGHOUT. NO ABLATION WAS PERFORMED. IT WAS NOTED THAT THE PHYSICIAN DOES NOT BELIEVE THAT A BWI PRODUCT WAS RESPONSIBLE FOR THE INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 7259603 ↗
• MalfunctionJan 15, 2017Break; Detachment Of Device Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER. THE PHYSICIAN PLACED THE SMART TOUCH BIDIRECTIONAL CATHETER INTO AN 8 FRENCH SHEATH. PARTS OF THE CATHETER WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THERE WAS NO INTERNAL CATHETER COMPONENTS OR SHARP EDGES NOTED ON THE CATHETER. THE PHYSICIAN COULD NOT WITHDRAW THE CATHETER THROUGH THE 8FR SL1 SHEATH. THEREFORE, THE SHEATH AND CATHETER WERE WITHDRAWN AS A UNIT. IT WAS THEN NOTED THAT A SMALL PIECE OF THE SHEATH WAS STUCK UNDER THE ELECTRODE OF THE CATHETER¿S TIP. THE RESISTANCE WITH THE SHEATH DESCRIBED WAS ASSESSED AS NOT REPORTABLE AS INTERFERENCE OR FRICTION BETWEEN DEVICES IS A KNOWN OCCURRENCE. IF RESISTANCE IS ENCOUNTERED, THE SYSTEM MAY BE WITHDRAWN AS A UNIT. THIS IS A COMMON PRACTICE DURING PROCEDURES. SINCE THE VAST MAJORITY OF EP PROCEDURES UTILIZE MULTIPLE DEVICE EXCHANGES, AN INCREASED POTENTIAL FOR PATIENT INJURY WAS REMOTE. THE FOREIGN MATERIAL (A SMALL PIECE OF THE SHEATH) NOTED UNDER THE ELECTRODE OF THE CATHETER¿S TIP WAS ASSESSED AS A REPORTABLE MALFUNCTION AS I

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6252929 ↗
• InjuryDec 7, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A PERICARDIAL EFFUSION, WHICH REQUIRED MEDICATION. DURING THE ABLATION PHASE, THE PATIENT'S BLOOD PRESSURE DECREASED. A PERICARDIAL EFFUSION WAS CONFIRMED USING INTRACARDIAC ECHOCARDIOGRAM. THE ABLATION PROCEDURE WAS ABORTED, CATHETERS REMOVED AND PROTAMINE WAS ADMINISTERED TO THE PATIENT. NO FURTHER INTERVENTION WAS NECESSARY. THE PATIENT WAS CLOSELY MONITORED AND WAS STABLE AT THE TIME THIS COMPLAINT WAS REPORTED TO BIOSENSE WEBSTER INC. (BWI). THE PATIENT DID NOT REQUIRED HOSPITALIZATION DUE TO THE ADVERSE EVENT. THE PATIENT HAS SINCE FULLY RECOVERED. THERE WERE NO KNOWN FACTORS THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE PHYSICIAN DID NOT PROVIDE A CASUALTY OPINION FOR THIS EVENT. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL SL1 CATH AND BROCKENBROUGH NEEDLE. IN ADDITION, A ST. JUDE MEDICAL SL1 SHEATH WAS USED. THE PATIENT RECEIVED ANTICOAGULATION AND THE ACTIVATED CLOTTING TIME WAS MAINTAINED AT 300-350 SECONDS. THE GENERATOR WAS IN POWER CONTROL MODE, WITH STANDARD CUTOFFS. TEMPERATURE AT LAST A

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 6151373 ↗
• InjuryNov 9, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE AND CARDIAC ARREST WHICH REQUIRED AN EMERGENT PERICARDIOCENTESIS AND SURGICAL INTERVENTION. THE PATIENT'S DIAGNOSIS PRE-PROCEDURE WAS ATRIAL FIBRILLATION (AFIB) AND HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY (HOCM). DURING THE PROCEDURE, A CARDIAC PERFORATION WAS NOTICED AND THE PATIENT CODED. THEY PERFORMED AN EMERGENT PERICARDIOCENTESIS AND REMOVED 100CC OF FLUID. LATER THAT EVENING THEY PERFORMED A CT SURGICAL REPAIR. THE PATIENT WAS REPORTED TO BE IN THE CRITICAL CARE UNIT. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS A PERFORATION WITH THE ABLATION CATHETER. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A NON BIOSENSE WEBSTER INC. PRODUCT. THE SHEATH WAS A ST. JUDE MEDICAL SL-1. THE INJURY OCCURRED HALFWAY THROUGH THE PROCEDURE. SOME ABLATION HAD BEEN PERFORMED. THE SITE OF INJURY WAS NOT KNOWN AS NOT SURE IF THE INJURY OCCURRED DURING THE RADIO FREQUENCY OR WHILE MANIPULATING THE CATHETER AROUND THE ATRIA. THEY HAD JUST FINISHED THE LESION SET ON

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade

  MAUDE report 6091782 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031, P040036. One submission often covers many models, so check the product and lot details in each record.

• Z-0169-2023 · Sep 7, 2022 · Open, Classified
  THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• Z-0980-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0983-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0979-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0982-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0981-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0057-06 · Aug 8, 2005 · Terminated
  Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P