NaviStar NS7TCBL174HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846835008531), received between Mar 8, 2017 and Mar 20, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (P990025); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMar 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIWANI S, AKHAVAN D, REDDY M, NOHERIA A. CARDIAC STEREOTACTIC RADIOTHERAPY FOR REFRACTORY VENTRICULAR TACHYCARDIA IN A PATIENT WITH WIRELESS LEFT VENTRICULAR ENDOCARDIAL STIMULATION SYSTEM. HEARTRHYTHM CASE REP. 2023 SEP 1;9(11):818-822. DOI: 10.1016/J.HRCR.2023.08.013. PMID: 38023677; PMCID: PMC10667127. OBJECTIVE/METHODS/STUDY DATA: CASE REPORT OF 83 YEAR OLD MAN WITH HISTORY OF CORONARY ARTERY DISEASE, ISCHEMIC CARDIOMYOPATHY WITH LV APICAL INFARCT AND LV EJECTION FRACTION (LVEF) (B)(6), CHRONIC NYHA CLASS III HEART FAILURE STATUS POST CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEFIBRILLATOR PLACEMENT, RECURRENT VT, UNDERLYING LEFT BUNDLE BRANCH BLOCK, PAROXYSMAL ATRIAL FIBRILLATION, AND CHRONIC KIDNEY DISEASE. HE HAD MULTIPLE PRESENTATIONS WITH SUSTAINED VT REQUIRING IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) SHOCKS, WHICH CONTINUED DESPITE AMIODARONE AND MEXILETINE. HE UNDERWENT ENDOCARDIAL LV CATHETER MAPPING/ABLATION WITH NAVISTAR (BIOSENSE WEBSTER, IRVINE, CA) REMOTE MAGNETIC NAVIGATION CATHETER. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSI

  Patient problems: Cardiac Tamponade

  MAUDE report 18938525 ↗
• InjuryJan 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT-SIDE ATRIAL TACHYCARDIA ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC ARREST THAT REQUIRED CHEST COMPRESSION, MEDICATION AND PROLONGED HOSPITALIZATION. THE PATIENT ALSO EXPERIENCED A SMALL PERICARDIAL EFFUSION THAT DID NOT REQUIRE FURTHER INTERVENTION. ALSO, THROMBOSIS WAS DISCOVERED IN PERICARDIUM THAT REQUIRED SURGICAL INTERVENTION TO REMOVE. WHILE PERFORMING A RIGHT-SIDED ATRIAL TACHYCARDIA CASE, THE PATIENT'S HEART STOPPED BEATING AND THEY WENT INTO CARDIAC ARREST. MEDICAL INTERVENTION PROVIDED WERE CHEST COMPRESSIONS AND ADMINISTERING OF EPINEPHRINE TO THE PATIENT. A SMALL PERICARDIAL EFFUSION WAS CONFIRMED ON ECHOCARDIOGRAM BUT DUE TO THE SIZE OF THE EFFUSION, THEY DID NOT PERFORM ANY FURTHER MEDICAL INTERVENTION. PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATED THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE ADVERSE EVENT WAS DUE TO THE ABLATION CATHETER. COMPRESSIONS WERE PROVIDED IMMEDIATELY. AFTER THE PATIENT WAS STABLE AND AFTER MONITORING THE CLOT, IT WAS DECIDED THAT CARE SHOULD BE PROVIDED TO REMOVE THE CLOT FROM THE PERICARDIUM (TAP) IN A SEPARATE

  Patient problems: Cardiac Arrest; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 18556399 ↗
• InjuryApr 29, 2021High Readings; Patient Device Interaction Problem; High Readings; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT ((B)(6)) UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION) AND CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)). DURING THE PROCEDURE, AFTER TRANSSEPTAL ACCESS WAS OBTAINED AND MAPPING WAS PERFORMED, SOME ABLATION WAS PERFORMED NEAR/UNDER THE MITRAL VALVE. THE PATIENT'S HEART RHYTHM CHANGED TO JUNCTIONAL, THEN BRADYCARDIA. ANESTHESIA THEN NOTED A DROP IN BLOOD PRESSURE (AT THIS TIME, THE ABLATION CATHETER WAS BEING REPOSITIONED IN THE HEART). PATIENT WENT INTO CARDIAC ARREST AND CPR WAS STARTED. FLUORO WAS THEN USED TO LOOK AT THE HEART, AND THE HEART WAS NOT MOVING. A STAT TRANSTHORACIC ECHOCARDIOGRAM (TEE) WAS ORDERED, WHICH SHOWED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND AN UNKNOWN AMOUNT OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE AND AUTO-TRANSFUSED BACK INTO THE PATIENT. PATIENT REMAINED UNSTABLE, AND THE SURGICAL TEAM WAS CALLED. OPEN-CHEST SURGERY WAS REQUIRED TO REPAIR A HOLE IN THE LEFT VENTRICLE (LV), PATIENT¿S CONDITION IMPROVED AND WAS REPO

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 11750087 ↗
• InjuryOct 17, 2018Adverse 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 FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. DURING MAPPING PHASE, A CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHO (TEE). REMINDER OF THE PROCEDURE WAS ABORTED. THE PHYSICIAN HAD TO OPEN PATIENT¿S CHEST TO DRAIN THE BLOOD AND CLOSE THE PERFORATION IN THE HEART. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER CARDIAC SURGERY. ABLATION WAS NOT PERFORMED, AND THE PATIENT REMAINS IN SVT. THE PATIENT WAS TRANSFERRED TO PEDIATRIC INTENSIVE CARE UNIT (PICU) AND REQUIRED EXTENDED HOSPITALIZATION. PATIENT¿S OUTCOME IS IMPROVED. PATIENT¿S ANATOMY WAS CITED AS A FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. THERE WERE NO ERROR MESSAGES DISPLAYED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THE GENERATOR WAS NOT IN USE AT THE TIME OF THE INJURY AS NO ABLATION WAS PERFORMED. THE PATIENT RECEIVED ANTICOAGULANT (UNSPECIFIED) DURING THE PROCEDURE. THE ACTIVATED CLOTTING TI

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 7974881 ↗
• InjuryMar 8, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT)/ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) WITH A NAVISTAR CATHETER AND SUFFERED A HEART BLOCK AV THIRD DEGREE REQUIRING CARDIAC PACEMAKER INSERTION. INITIALLY, ABLATION WAS BEING PERFORMED ON THE RIGHT ATRIAL SEPTUM, BUT THE PHYSICIAN WAS UNABLE TO ELIMINATE THE PATHWAY. WHEN THE NAVISTAR CATHETER WAS CHANGED FROM THE D CURVE TO THE B CURVE AND MOVED TO A DIFFERENT LOCATION, A HEART BLOCK OCCURRED. PHYSICIAN PROCEEDED WITH THE CASE. CS CATHETER WAS REPLACED. ABLATION WAS CONDUCTED IN THE LEFT ATRIUM AND THEN THE RIGHT ATRIUM AGAIN. PHYSICIAN WAS UNABLE TO COMPLETELY ELIMINATE THE BUNDLE OF KENT. PATIENT WENT INTO COMPLETE AV BLOCK AND THE PROCEDURE ENDED. INTERVENTION WAS A TEMPORARY EXTERNAL PACEMAKER. PATIENT SCHEDULED FOR A PERMANENT PACEMAKER TO BE IMPLANTED 3 DAYS POST-PROCEDURE. PATIENT REQUIRED EXTENDED HOSPITALIZATION FOR CARDIAC PACEMAKER IMPLANTATION. PATIENT OUTCOME IS UNCHANGED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED AND NOT RELATED TO BWI PRODUCTS.

  Patient problems: Complete Heart Block

  MAUDE report 6387043 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990025. One submission often covers many models, so check the product and lot details in each record.

• Z-0369-2010 · Oct 2, 2008 · Terminated
  Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02