THERMOCOOL SMARTTOUCH SF D134805Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,106 adverse event reports that list this exact device (DI 10846835010183), received between Nov 7, 2016 and Sep 25, 2026 — classified as 176 deaths, 2,636 injuries, 1,294 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1,887 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (P030031); 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.

Recalls naming this device

1. Sep 7, 2022Open, Classified

   Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

   Z-0169-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,106 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Patient Device Interaction Problem

  Patient problems: Ischemic Heart Disease; Stenosis

  MAUDE report 50905987 ↗
• MalfunctionSep 25, 2026Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905777 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904050 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50891896 ↗
• InjurySep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Patient Device Interaction Problem

  It was reported that a patient underwent an ablation procedure with two (2) THERMOCOOL SMARTTOUCH SF catheters and the patient experienced a cerebrovascular accident (CVA) which required hospitalization and an interventional radiology procedure.It was initially reported there were no errors on the system, and force values were normal. Then the Smartablate Generator displayed ¿HI¿ force reading when ablation was applied. The catheter was re-zeroed, same problem occurred, replaced the cable but same problem, replaced catheter and the issue resolved issue.The customer's reported force issue is not considered to be MDR Reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.Hours after procedure, the patient became confused and irritable with mental status change. An MRI was done which confirmed the CVA/stroke. Interventional radiologist did an unknown procedure. Patient required extended hospitalization as a result of the event. Patient's vision has been affected as the patient reported blindness as a result of the CVA.The physician¿s opinion on the cause of this adverse event is that it is not related to

  Patient problems: Stroke/CVA

  MAUDE report 50863493 ↗
• MalfunctionSep 18, 2026Communication or Transmission Problem; Impedance Problem; Temperature Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812808 ↗
• InjurySep 3, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 50576868 ↗
• InjurySep 2, 2026Patient Device Interaction Problem

  Patient problems: Heart Block

  MAUDE report 50573398 ↗
• InjurySep 1, 2026Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation ablation with a THERMOCOOL SMARTTOUCH SF catheter and the patient experienced pericardial effusion that required pericardiocentesis and surgical intervention.Force sensor error happened when procedure was about to complete. The user was informed about absence of force sensing due to the sensor error, but the user decided to continue as the procedure since they were almost finished.An echocardiography was performed post-procedure and a pericardial effusion was found in patient. Pericardiocentesis was performed immediately and the patient was sent under intensive care at the ward. The patient needed a cardiothoracic surgeon to fix the tamponade and therefore required extended hospitalization.The cause of pericardial effusion could not be determined, whether it was related to use after force sensor error or was due to extensive point-by-point AF (atrial fibrillation) ablation performed during procedure.

  Patient problems: Cardiac Tamponade

  MAUDE report 50547952 ↗
• InjuryAug 31, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with a THERMOCOOL SMARTTOUCH SF Catheter and the patient experienced cardiac perforation which required pericardiocentesis and surgical intervention.During the procedure, 17 ablations were performed outside of the pulmonary veins. While ablating in the right ventricular outflow tract, the patient¿s blood pressure dropped. A pericardial effusion was diagnosed via intracardiac echocardiography (ICE). Pericardiocentesis was performed by the physician. The patient was stable and was transferred to the operating room for further surgical intervention. Patient has fully recovered.Physician¿s opinion on the cause of the event is that there was a perforation during ablation or catheter manipulation.

  Patient problems: Cardiac Perforation

  MAUDE report 50528618 ↗
• MalfunctionAug 31, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525633 ↗
• InjuryAug 27, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with an THERMOCOOL SMARTTOUCH SF Catheter and the patient experienced cardiac tamponade which required pericardiocentesis. During the ablation phase, while using Biosense Webster product, the left pulmonary vein (PV) was isolated however the right PV was not yet isolated. After pacing was performed to check the block, a decrease in blood pressure was observed. Blood pressure was 69/48. Echocardiography was performed and pericardial effusion was observed. Pericardial drainage was performed and the blood pressure stabilized to 129/90. The ablation was discontinued, and the patient was transported to another hospital for extended hospitalization. Physician's assessment of health hazard is non-serious (moderate/mild). The cause of the event is unknown, but the physician does not believe the event was caused by the product. There were no abnormalities observed prior to or during product use.

  Patient problems: Cardiac Tamponade

  MAUDE report 50466591 ↗
• InjuryAug 26, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an ablation procedure with a THERMOCOOL SMARTTOUCH SF catheter and experienced heart block and cardiac tamponade which required pericardiocentesis.During ablation to the slow pathway, transient atrioventricular (AV) block occurred. After the patient left the room, cardiac tamponade was identified. Drainage was performed and 300mL was drained and the patient condition improved. No additional intervention was required for the AV block, as AV conduction recovered following pericardial drainage. The patient required extension of hospitalization.Physician¿s opinion regarding the cause of the AV block and cardiac tamponade is they are not entirely sure, but it may have been related to edema or thermal injury affecting the AV node. The ablation site was more than 20 mm away from the His bundle. Procedural activated clotting time was around 350 seconds. Transseptal puncture was not performed. About three to four radiofrequency ablations to slow pathway, outside the pulmonary veins, were performed. There was no evidence of steam pop. Correct catheter settings were selected on the generator. There were no issues with flow rate change at the start of a

  Patient problems: Cardiac Tamponade; Heart Block

  MAUDE report 50444909 ↗
• MalfunctionAug 21, 2026Obstruction of Flow

  It was reported that a patient underwent an Atrioventricular nodal reentrant tachycardia (AVNRT) ablation procedure with a THERMOCOOL SMARTTOUCH SF catheter which had an irrigation issue during use on the patient.It was initially reported by the customer that the new THERMOCOOL SMARTTOUCH® SF Catheter was not irrigating at all and no fluid was coming out of the tip of the THERMOCOOL SMARTTOUCH® SF Catheter. The caller reported that the lab staff attempted to aspirate the THERMOCOOL SMARTTOUCH® SF Catheter, without resolution. The THERMOCOOL SMARTTOUCH® SF Catheter was replaced and the issue was resolved. The procedure continued with no further issues. There was no patient consequence. The customer's reported occlusion was not considered to be MDR Reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 29-Jul-2026, additional information was received indicating the catheter was used on the patient and suspected to have the irrigation issue. There was no errors noted from the nGEN Pump and when ablating, there was a high temperature error. It was then noticed that the tubing had disconnected from the

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50361710 ↗
• InjuryAug 20, 2026Patient Device Interaction Problem

  Patient problems: Heart Block

  MAUDE report 50359673 ↗
• InjuryJul 29, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an IdVT (idiopathic ventricular tachycardia) ablation with a ThermoCool SmartTouch SF and the patient experienced steam pop / VSD (ventricular septal defect) that required surgical intervention.It was reported that the there was a steam pop that occurred in the middle/end of the procedure. The physician stated they felt the steam pop occurred and the SC2000 Ultrasound Machine showed the tip of the catheter was "smokey" in that area. The medical team came off ablation right away and moved to a different location. It was originally reported that there was no injury to the patient and there were no other issues. The catheter was not replaced.Then it was discovered on (b)(6) 2026 that the patient suffered a VSD (ventricular septal defect) that was believed to have been caused by the steam pop. The patient was admitted to the hospital and the VSD was confirmed by echo. The patient underwent a VSD closure. The last known status was the patient was stable.Both RF (radiofrequency) and PFA (pulse field ablation) were used during the case. 2 indifferent electrodes were used with RF.The STSF catheter was the ablation catheter used.

  Patient problems: Cardiac Perforation; Intraoperative Cardiac Injury

  MAUDE report 50073268 ↗
• InjuryJul 29, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an idiopathic ventricular tachycardia (IdVT) ablation procedure and the patient experienced pericardial effusion that required pericardiocentesis.First, unrelated to the event, it was reported that an OPTRELL catheter had a black distal electrode and was not creating a matrix. The catheter was disconnected and reconnected, but the issue remained. The catheter cable was replaced, but the issue remained. The Signal Processing Unit (SPU) was disconnected and reconnected, but the issue remained. The SPU was rebooted, but the issue remained. The catheter was replaced, and the problem was resolved. The case continued.The reported mapping issue with the OPTRELL catheter is not considered to be a reportable issue as the potential risk that it could cause or contribute to a serious injury or death is remote.Then it was reported that a pericardial effusion was noticed on ultrasound Intracardiac Echocardiography (ICE) catheter at the time the patient was complaining of chest pain. The effusion was confirmed with X-ray, ultrasound, and blood pressure readings. A pericardiocentesis was performed on the patient. The patient's last known status was stable.

  Patient problems: Cardiac Tamponade

  MAUDE report 50071308 ↗
• MalfunctionJun 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THERE WAS A FORCE SENSOR ERROR. THERE WERE NO PATIENT CONSEQUENCES. THE CUSTOMER'S REPORTED FORCE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 14-MAY-2026, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466011 ↗
• InjuryJun 10, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA / LEFT SIDED ATRIAL FLUTTER ABLATION WITH A STSF CATHETER (THERMOCOOL SMARTTOUCH SF) AND THE PATIENT EXPERIENCED PE (PERICARDIAL EFFUSION) THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. THE PATIENT ALSO EXPERIENCED CARDIAC ARREST (PEA - PULSELESS ELECTRICAL ACTIVITY) THAT REQUIRED COMPRESSIONS. AFTER THEY MAPPED THE FLUTTER, AND STARTED BURNING, THE PATIENT HAD MOVED. THEY HAD TO RE-INITIALIZE, MAKE A NEW MAP AND BUILT FAM, AND STARTED BURNING AGAIN. THEY WERE NOT SURE ON THE LOCATION, AND ON ICE (INTRACARDIAC ECHOCARDIOGRAPHY), IT WAS DISPLAYED AS IF THEY WERE OUTSIDE OF THE LEFT ATRIUM. THE PHYSICIAN PULLED THE CATHETER BACK, AND THEY NOTICED PRESSURES DROPPED AND NOTICED THE EFFUSION. THE EFFUSION WAS CONFIRMED BY USING ICE, LOOKING AT FAM, PRESSURE GOING TO THE MANIFOLD, AND FLUOROSCOPY. PERICARDIOCENTESIS WAS PERFORMED ON THE PATIENT, AND 200ML WAS DRAINED. EMERGENCY MEDICAL TEAM (¿911¿) WAS CALLED, AND THE PATIENT DID HAVE PEA (PULSELESS ELECTRICAL ACTIVITY) FOR A "LITTLE BIT" AND COMPRESSIONS HAD TO BE DONE. THEY GOT THE PATIENT BACK, FINISHED DRAINING, AND THE PATIENT WAS THEN OFF TO THE HO

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 25460742 ↗
• MalfunctionMay 27, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A LIFTED ELECTRODE SLID DOWN AND INTERNAL COMPONENTS WERE EXPOSED LEAVING A HOLE IN THE SURFACE OF THE PEBAX. INITIALLY IT WAS REPORTED THAT THERE WAS A MANUFACTURING ANOMALY ON THE CATHETER TIP. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS DIFFICULTY DURING INSERTION IN THE SHEATH. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2026, IT WAS IDENTIFIED THAT THERE WAS REDDISH MATERIAL INSIDE THE PEBAX, A LIFTED ELECTRODE SLID DOWN AND INTERNAL COMPONENTS WERE OBSERVED EXPOSED LEAVING A HOLE IN THE SURFACE OF THE PEBAX. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A LIFTED ELECTRODE SLID DOWN AND INTERNAL COMPONENTS WERE EXPOSED LEAVING A HOLE IN THE SURFACE OF THE PEBAX ON (B)(6) 2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311268 ↗
• InjuryMay 21, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED DRAINAGE. DURING THE LEFT ATRIAL GEOMETRY ACQUISITION, THE ABLATION CATHETER DISENGAGED FROM THE LEFT ATRIUM. WHILE REINSERTING THE CATHETER THROUGH THE BROCKENBROUGH HOLE (TRANSSEPTAL PUNCTURE SITE), THE CONTACT FORCE BRIEFLY REACHED 50G (THE CATHETER WAS PUSHED TOO HARD). AFTER SOME TIME, THE PATIENT¿S BLOOD PRESSURE DROPPED. CARDIAC TAMPONADE OCCURRED. AFTER DRAINAGE, BLOOD PRESSURE RETURNED TO NORMAL AND CONSCIOUSNESS RECOVERED. PATIENT FULLY RECOVERED. PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. AFTER MAPPING, THE ABLATION CATHETER CAME OUT OF THE LEFT ATRIUM. EXCESSIVE FORCE WAS APPLIED TO THE CATHETER DURING REINSERTION THROUGH THE TRANSSEPTAL PUNCTURE SITE. THERE WAS NO MALFUNCTION WITH THE CATHETER ITSELF. NO ERROR CODE WAS DISPLAYED. NO ABLATION WAS PERFORMED.

  Patient problems: Cardiac Tamponade

  MAUDE report 25250809 ↗
• MalfunctionMay 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THERE WAS WRONG INFORMATION WITH THE FORCE SENSOR. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED FORCE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON (B)(6) 2026, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229377 ↗
• MalfunctionMay 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND DURING THE OPERATION, FORCE VALUE JUMPS FROM 4 GRAMS TO 50 AFTER STARTING THE ABLATION. THE FORCE CURVE WAS EXACTLY THE SAME, LIKE THE POWER CURVE ON SMARTABLATE GENERATOR. CABLE REPLACEMENT DID NOT FIX THE ISSUE. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191993 ↗
• MalfunctionMay 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING THE PROCEDURE ITSELF, THE CATHETER GAVE A FORCE SENSOR ERROR. THE CABLE WAS CHANGED TWICE, THE PATIENT INTERFACE UNIT WAS RESTARTED, BUT THE FORCE SENSOR ERROR STILL CONTINUED. THE CATHETER ITSELF WAS CHANGED AND THE ISSUE RESOLVED. NO FURTHER DETAILS WERE PROVIDED REGARDING COMPLETION OF THE PROCEDURE. HOWEVER, NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187036 ↗
• MalfunctionMay 13, 2026Display or Visual Feedback Problem; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT CATHETER ICON WAS MOVING ERRATICALLY DURING RF DELIVERY ONLY. THERE WAS ALSO AN UNKNOWN, INTERMITTENT MAGNETIC DISTORTION ERROR PRESENT ON THE CARTO 3 SYSTEM. TO TROUBLESHOOT THEY EXCHANGED THE INDIFFERENT ELECTRODES, EXCHANGED THE CABLE TO THE CATHETER, WITHOUT RESOLUTION. THE CATHETER WAS EXCHANGED TO RESOLVE THE ERROR AND CONTINUE THE CASE SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED SENSOR AND VISUALIZATION ISSUES IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 17-APR-2026, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163208 ↗

Recalls under the same FDA submission

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

• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• 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-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-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-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-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-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