NaviStarRecalls & reported problems across all models

We found 5 models of NaviStar by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2016 and Feb 19, 2026 — classified as 2 deaths, 61 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (46 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NaviStar problems

NaviStar models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NaviStar NS7TCDL174HS

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 death44 reports
• NaviStar NS7TCFL174HS

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 death27 reports
• NaviStar NS7TCBL174HS

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  5 reports
• NaviStar NS7TCJL174HS

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  4 reports
• NaviStar NS7TCCL174HS

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report

Recent NaviStar adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A NAVISTAR. THE PATIENT EXPERIENCED AN AV BLOCK INITIALLY TREATED WITH TEMPORARY PACEMAKER. THE OUTCOME OF THE ADVERSE EVENT WAS UNCHANGED. CONDUCTION RECOVERED TO A 2:1 ATRIOVENTRICULAR BLOCK BUT DID NOT NORMALIZE; A PACEMAKER WAS SUBSEQUENTLY IMPLANTED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF PACEMAKER IMPLANTATION. AV BLOCK OCCURRED. WHILE WAITING AFTER THE ABLATION WAS COMPLETED, SINCE THE PATIENT REMAINED IN AV BLOCK, TEMPORARY PACEMAKER WAS INSERTED AND THE PATIENT LEFT THE ROOM. NO EXTENDED HOSPITALIZATION. THE METHOD OF CF MONITORING WAS VISITAG. THE COLORING SETTINGS FOR VISITAG WAS TOTAL TIME. NO ABNORMALITIES WERE OBSERVED PRIOR/DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 11-FEB-2026. THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PROCEDURE. AT THE ONSET OF JUNCTIONAL RHYTHM, DID NOT NOTICE IT DISPLAYED ON THE RECORDING SYSTEM. THE OUTCOME OF THE ADVERSE EVENT WAS UNCHANGED. CONDUCTION RECOVERED TO A 2:1 ATRIOVENTRICULAR BLOCK BUT DID NOT NORMALIZE; A PACEMAKER WAS SUBSEQUENTLY

  Patient problems: Heart Block

  MAUDE report 24398002 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING CARDIAC ABLATION PROCEDURE WITH NAVISTAR CATHETER, THE PATIENT EXPERIENCED CORONARY VASOSPASM TREATED WITH PERCUTANEOUS BALLOON INFLATION AND INTRA-AORTIC BALLOON PUMP (IABP) PLACED, WHICH REQUIRED PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT DURING AORTIC CORONARY CUSP ABLATION WITH NAVISTAR CATHETER, CONTRAST EXAMINATION WAS PERFORMED BECAUSE THE PATIENT COMPLAINED OF CHEST PAIN. CORONARY VASOSPASM WAS OBSERVED IN A SEGMENT OF THE LEFT CORONARY ARTERY, AND PERCUTANEOUS BALLOON INFLATION WAS PERFORMED. THE ABLATION WAS STOPPED AT THAT POINT. AFTER THE PROCEDURE, THE PATIENT'S SYMPTOMS WERE IMPROVING; HOWEVER, AN IABP WAS PLACED, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN¿S ASSESSMENT OF THE HEALTH HAZARD WAS NON-SERIOUS (MODERATE/MINOR). EXTENDED HOSPITALIZATION WAS NOTED. THE COLORING SETTINGS FOR VISITAG WAS TAG INDEX. THE VISITAG ADDITIONAL FILTERS USED WAS IMPEDANCE DROP. THE RELATIONSHIP WITH THE PRODUCT WAS CAUSAL. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED.

  Patient problems: Vasospasm

  MAUDE report 23824323 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THAT DURING AN ABLATION PROCEDURE WITH A NAVISTAR CATHETER, THE PATIENT EXPERIENCED HEART BLOCK TREATED WITH A PERMANENT PACEMAKER. IT WAS REPORTED THAT THE PATIENT HAD A COMPLETE HEART BLOCK. DURING ABLATION, AND REALLY FAR FROM THE HIS, TWO DROPPED/NON-CONDUCTING ATRIAL BEATS WERE NOTICED. THE PHYSICIAN CAME OFF ABLATION AND VENTRICULAR PACED THE PATIENT FOR CONDUCTION. THE PROCEDURE WAS ABORTED. THE INJURY WAS CONFIRMED BY VISUALIZING THE SIGNALS DISPLAYED ON THE CARTO 3 SYSTEM. A PERMANENT PACEMAKER WAS PLACED IN THE PATIENT. THE LAST KNOWN PATIENT STATUS WAS REPORTED AS STABLE. GENERATOR USED FOR ABLATION WAS A NGEN. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS ANATOMY RELATED. THE PATIENT REQUIRED OVERNIGHT HOSPITALIZATION.

  Patient problems: Heart Block

  MAUDE report 22524623 ↗
• InjuryJul 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH NAVISTAR CATHETER, THE PATIENT EXPERIENCED AN IMPAIRED SEPTAL MOVEMENT. AFTER THE PROCEDURE WAS COMPLETED USING THE NAVISTAR CATHETER, ¿THE MOVEMENT OF SEPTUM HAS BECOME IMPAIRED¿. THERE WAS NO EXTENDED HOSPITALIZATION REQUIRED. CAUSAL RELATIONSHIP WITH PRODUCT WAS UNKNOWN. THERE WERE NO ERROR MESSAGES OBSERVED ON HARDWARE/CAPITAL EQUIPMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED TO PROVIDE FURTHER DETAILS ABOUT THE REPORTED EVENT. HOWEVER, NO INFORMATION HAS BEEN PROVIDED.

  Patient problems: Intraoperative Cardiac Injury

  MAUDE report 22455520 ↗
• InjuryJul 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT (ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED HEMOPERICARDIUM THAT REQUIRED PERICARDIOCENTESIS. A PATIENT WHO HAD A RADIOFREQUENCY ABLATION WAS DIAGNOSED WITH HEMOPERICARDIUM BY ECHOCARDIOGRAPHY ABOUT 20 MINUTES AFTER THE PROCEDURE. AFTER THAT, A PUNCTURE OF THE PERICARDIUM WAS PERFORMED AND 120 ML OF VENOUS BLOOD WAS EVACUATED. THE NEXT DAY DRAINAGE WAS REMOVED FROM THE PERICARDIUM CAVITY. THE PATIENT FELT WELL. PATIENT FULLY RECOVERED HOWEVER REQUIRED 2 DAYS OF EXTENDED HOSPITALIZATION. DURING ABLATION, NOTHING UNUSUAL HAPPENED, EVERYTHING WAS REPORTED TO BE STANDARD. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PATIENT'S CONDITION / PROCEDURE. NO EVIDENCE OF STEAM POP WAS NOTED.

  Patient problems: Cardiac Tamponade

  MAUDE report 22375614 ↗
• InjuryJun 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION, AND THE PATIENT EXPERIENCED TRANSIENT 3RD DEGREE HEART BLOCK. THE PATIENT DEVELOPED A TRANSIENT THIRD-DEGREE HEART BLOCK FOLLOWING RADIOFREQUENCY (RF) APPLICATION, DURING AN AVNRT PROCEDURE. THE HEART BLOCK RESOLVED, AND THE PATIENT REMAINED STABLE. NO INTERVENTION WAS PROVIDED. THE PATIENT FULLY RECOVERED AND DID NOT REQUIRE EXTENDED HOSPITALIZATION.

  Patient problems: Heart Block

  MAUDE report 22332699 ↗
• InjuryJun 17, 2025Device Contamination with Body Fluid; Patient Device Interaction Problem; Device Contamination with Body Fluid; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A NAVISTAR CATHETER, THE PATIENT EXPERIENCED A BRIEF AV BLOCK, IMPAIRED AV CONDUCTION, 2:1 CONDUCTION TREATED WITH TEMPORARY RIGHT VENTRICLE (RV) CATHETER. DURING THE AVNRT CARTO PROCEDURE, A BRIEF AV BLOCK WAS OBSERVED, FOLLOWED BY IMPAIRED AV CONDUCTION. THIS OCCURRED AFTER THE LAST ABLATION POINT WITHOUT ANY PRIOR SIGNS. ABLATION WAS SUFFICIENTLY FAR AWAY FROM THE HIS. INITIAL ABLATION POINTS WERE PERFORMED AT 35 WATTS, THEN INCREASED TO 40 W. TEMPERATURE MODE. SMART ABLATE GENERATOR. THE PATIENT LEFT THE TABLE WITH A 2:1 CONDUCTION/AV BLOCK NOT COMPLETE, AND A TEMPORARY RV CATHETER. HOWEVER, HE IMPROVED DURING THE WAITING PERIOD. CHARGING AT THE CATHETER TIP WAS CONFIRMED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS MYOCARDIAL EDEMA DUE TO RF ABLATION OF THE SLOW PATHWAY REGION, AND THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED.

  Patient problems: Heart Block

  MAUDE report 22253838 ↗
• MalfunctionMay 8, 2025Coagulation in Device or Device Ingredient; Off-Label Use; Device Contamination with Body Fluid; Device Sensing Problem; Coagulation in Device or Device Ingredient; Off-Label Use; Device Contamination with Body Fluid; Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR CATHETER AND THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. THE NAVISTAR (4MM) WAS USED FOR AN ATRIAL TACHYCARDIA (AT) ABLATION RIGHT SIDED. AFTER SEVERAL BURNS, PHYSICIAN COMPLAINED THAT POWER / TEMPERATURE RATIO WAS BAD AND TOOK THE CATHETER OUT. VISIBLE CHARRING ON TIP AFTER 60W/60°C ABLATION SETTING. A THERMOCOOL WAS USED TO TREAT THE PATIENT FURTHER. PROCEDURE DELAYED BY 4 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 15-APR-2025. THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. THE PHYSICIAN DID NOT REALLY CONSIDER THAT THE AMOUNT OF CHAR CAUSED A POTENTIAL RISK TO THIS PATIENT SINCE IT WAS A RIGHT-SIDED ABLATION. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGE; JUST BAD POWER OUTPUT (HIGH TEMPERATURE AND LOW POWER) AFTER SEVERAL PROBABLY BECAUSE OF ALREADY CHARRED TIP. USED NON-IRRIGATED CATHETER. THE GENERATOR THRESHOLD WAS 60W/60'C. THE NOTED TEMPERATURE, IMPEDANCE AND POWER WERE NORMAL IN THE BEGINNING. WORSE AFTER SEVERAL BURNS (HIGH POWER 60'C AND BAD POWER ~ 15W). STANDARD HEPARIN BOLUS BEFORE ABLATION, NO ACT BECAUSE RIGHT SIDED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991036 ↗
• InjuryMar 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION WITH A NAVISTAR AND THE PATIENT EXPERIENCED A COMPLETE AV BLOCK THAT REQUIRED PROLONGED HOSPITALIZATION. DURING THE PROCEDURE, AN AV BLOCK OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. PATIENT'S CONDITION WORSENED AND COMPLETE ATRIOVENTRICULAR BLOCK OCCURRED. PATIENT REQUIRED EXTENDED HOSPITALIZATION TO MONITOR THE PATIENT'S CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PROCEDURE RELATED. NO PUMP USED.

  Patient problems: Heart Block

  MAUDE report 21555765 ↗
• InjuryMar 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR AND THE PATIENT EXPERIENCED 1ST DEGREE HEART BLOCK / MYOCARDIAL EDEMA THAT REQUIRED MEDICATION. PATIENT LEFT 4 HOURS AFTER PROCEDURE AGAINST MEDICAL ADVICE. THE PATIENT CAME BACK A FEW DAYS LATER WITH PALPITATIONS. THE PATIENT WAS NOTICED TO HAVE TACHYCARDIA AND PROLONGED HV TIME (HIS BUNDLE TO THE VENTRICLE). PATIENT HAD A AV BLOCK 1ST DEGREE. THE PATIENT DID NOT HAVE THESE SYMPTOMS PRIOR TO LEAVING THE HOSPITAL POST PROCEDURE. THE INTERVENTION PROVIDED WAS SYSTEMICALLY GLUCOCORTICOIDS DUE TO MYOCARDIAL EDEMA (PRESUMABLY) OVER 3 DAYS. PATIENT FULLY RECOVERED. UNDER THIS TREATMENT THE AV BLOCK DISAPPEARED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PATIENT CONDITION. THE SUSPECTED CAUSE OF THE MYOCARDIAL EDEMA WAS DUE TO RF-ABLATION OF THE SLOW PATHWAY; MAYBE A SIDE EFFECT BECAUSE OF THE NEAR DISTANCE. THE ADVERSE EVENT DIAGNOSIS WAS TRANSIENT AV BLOCK 1ST DEGREE.

  Patient problems: Heart Block; Tachycardia; Unspecified Tissue Injury

  MAUDE report 21505881 ↗
• InjuryFeb 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION AND THE PATIENT EXPERIENCED CHEST PAIN / ST ELEVATION THAT REQUIRED PROLONGED HOSPITALIZATION. DURING AN ABLATION PROCEDURE FOR THE TREATMENT OF SUPRAVENTRICULAR TACHYCARDIA TYPE AVNRT, THE ELECTROPHYSIOLOGIST PERFORMED ABLATIONS IN VARIOUS PLACES IN THE RIGHT ATRIUM USING A 4MM NAVISTAR CATHETER THAT DID NOT RESULT IN CESSATION OF THE ARRHYTHMIA. FOR THIS REASON, THE ELECTROPHYSIOLOGIST DECIDED TO MOVE FORWARD WITH WORKING WITH THE SAME CATHETER (4MM NAVISTAR), TO ABLATE IN THE LEFT ATRIUM, IN ORDER TO TRY TO STOP THE ARRHYTHMIA AND BEGAN PERFORMING ABLATIONS IN THE LEFT ATRIUM AS WELL. SINCE THE ARRHYTHMIA WAS NOT STOPPED, THE ELECTROPHYSIOLOGIST DECIDED TO CONTINUE ABLATING IN THE LEFT ATRIUM WITH A THERMOCOOL SMARTTOUCH SF CATHETER. BETWEEN THE 24TH AND 25TH ABLATION SESSION (THIS NUMBER INCLUDES THE TOTAL BURNS IN THE RIGHT AND LEFT ATRIUM TOGETHER WITH BOTH TYPES OF CATHETERS), ST-SEGMENT ELEVATIONS WERE OBSERVED ON THE PATIENT'S ELECTROCARDIOGRAM (ECG) AND THE PATIENT FELT CHEST PAIN. IT SHOULD BE NOTED THAT ST ELEVATIONS INDICATE A LACK OF BLOOD SUPPLY TO THE HEART MUSC

  Patient problems: Chest Pain; Ischemic Heart Disease

  MAUDE report 21454714 ↗
• MalfunctionJan 9, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE CATHETER WAS NOT RETRACTING BACK AND REMAINED IN A FIXED POSITION. PHYSICIAN NOTICED THAT THE DEVICE WAS NOT 'BEHAVING CORRECTLY', AND PULLED CATHETER OUT OF PATIENT AND NOTICED IT WAS NOT RETURNING TO NORMAL UNDEFLECTED POSITION. THERE WERE NO ISSUES WITH REMOVING THE CATHETER. THE PUSH PULL WAS WORKING, AND IT SEEMED THAT THE RESPONSE WAS NOT 1/1 WITH THE TIP OF THE CATHETER. IT WAS STUCK IN PARTIAL DEFLECTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21115198 ↗
• MalfunctionDec 19, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE MEDICAL TEAM NOTED STICKY FILM OVER THE TOP OF THE CATHETER. THE STICKY MATERIAL WAS HARD TO PEEL OFF THE TIP OF THE CATHETER AND NOT NOTICEABLE TO THE NAKED EYE UNTIL THE SURGICAL FELLOW SAID THAT THE CATHETER WAS TIGHT GOING INTO THE SHEATH. THE DEVICE WAS USED INSIDE THE PATIENT TO MAP. HOWEVER, THE DEVICE WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20982597 ↗
• MalfunctionOct 16, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED THAT THE CONNECTOR WAS DETACHED FROM THE HANDLE. DURING THE PROCEDURE ITSELF, THE MEDICAL TEAM DISCOVERED THAT THE CATHETER TIP WAS DEFECTIVE. THE TIP OF THE CABLE ENTRY ON THE CATHETER WOULD COME OFF. THE ISSUE WAS NOTED BEFORE USAGE, SO THIS DEVICE NEVER TOUCHED THE PATIENT. THE CATHETER WAS CHANGED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464151 ↗
• MalfunctionSep 6, 2024Failure to Sense; Communication or Transmission Problem; Failure to Sense; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR AND A TOTAL ECG SIGNAL LOSS OCCURRED. IT WAS INITIALLY REPORTED THAT THERE WAS AN ERROR 105. NO CATHETER WAS SHOWN, NO SIGNAL WAS ON THE ECG SYSTEM. THE CABLE WAS CHANGED AND THE ISSUE PERSISTED. THE CATHETER WAS CHANGED AND THE PROBLEM WAS GONE. THERE WAS NO PATIENT CONSEQUENCE. THE EVENT WAS INITIALLY CONSIDERED NOT REPORTABLE SINCE THE RISK TO THE PATIENT IS LOW. ON 26-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THERE WERE NO SIGNALS AT ALL SHOWING ON THE CARTO 3 OR BARD SYSTEMS WHILE THE CATHETER WAS IN THE PATIENTS BODY AND NO OTHER MONITOR AVAILABLE TO MONITOR THE PATIENTS HEART RHYTHM. AS SUCH, BASED ON THE NEW INFORMATION, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158011 ↗

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