NaviStar NS7TCJL174HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835008586), received between May 15, 2017 and Jun 25, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 12, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED HEART BLOCK WHICH REQUIRED STEROIDS AND PACING. DURING THE ABLATION THEY CAUSED A HEART BLOCK MOBITZ TYPE II. THEY WERE ABOUT 10 MM AWAY FROM THE HIS WHILE THEY WERE ABLATING. THE CALLER STATES THEY LOST CONDUCTION TO THE VENTRICLE. THEY PACED THE PATIENT VIA THE RV CATHETER AND THEY HAD RETROGRADE CONDUCTION. THEY KNEW THEY DID NOT TAKE OUT THE FAST PATHWAY. THEY THINK THEY MAY HAVE STIMULATED THE PARASYMPATHETIC NERVOUS SYSTEM. THE PATIENT WAS BEING MONITORED AND SHE DID START TO RECOVER A LITTLE BIT. THE REPORTER STATES THEY WILL FIND OUT TOMORROW IF THE PATIENT MADE A FULL RECOVERY. WHEN THE PATIENT LEFT THE LAB THEY WERE NOT BEING PACED. THE REPORTER STATES THE PATIENT RECEIVED SOME ISOPROPYL. THE PATIENT HAD SOME PROLONGATION AND THEY ARE SLOWLY RECOVERING. THE PATIENT WAS STARTING TO PACE ON THEIR OWN AND THEY WERE IN FIRST-DEGREE HEART BLOCK. THE PATIENT IS STABLE AND THEY ARE STAYING OVERNIGHT FOR OBSERVATION. THE PHYSICIAN FELT THEY MAY HAVE STIMULATED THE PARASYMPATHETIC NERVOUS SYST

  Patient problems: Heart Block

  MAUDE report 12613461 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE IN A 66 YEAR OLD FEMALE PATIENT WITH NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER, THE PATIENT DEVELOPED HEART BLOCK FOLLOWING RADIO FREQUENCY REQUIRING INSERTION OF PERMANENT PACEMAKER. DURING THE ABLATION PHASE, POST USE OF BIOSENSE WEBSTER, INC. PRODUCTS, THE PHYSICIAN FELT THAT DUE TO ALL OF THE PATIENT ARRHYTHMIAS IT WAS MEDICAL ACCEPTABLE TO PROCEED WITH AVNRT ABLATION THAT WAS EXTREMELY CLOSE TO THE ATRIOVENTRICULAR NODE (AVN) REGION WITH THE FULL UNDERSTANDING THAT IT COULD CAUSE COMPLETE HEART BLOCK. THE PHYSICIAN¿S OPINION IN RESPECT TO THE CAUSE OF THE EVENT IS THAT IT WAS RELATED TO PATIENT¿S CONDITION. THE PATIENT IS IMPROVED AFTER PACEMAKER IMPLANTATION. THE PHYSICIAN NOTED THAT DUE TO THE DIFFICULT ARRHYTHMIA THAT PROCEEDING WITH PACEMAKER AT THAT TIME INSTEAD OF THE FUTURE DATE WAS APPROPRIATE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION DUE TO SURGICAL INTERVENTION (NORMAL AFTER PACEMAKER IMPLANTATION).

  Patient problems: Complete Heart Block; No Code Available

  MAUDE report 9373787 ↗
• InjuryMay 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A NAVISTAR CATHETER AND SUFFERED AN ST SEGMENT ELEVATION MYOCARDIAL INFARCTION REQUIRING A CARDIAC CATHETERIZATION AND AN IMPELLA LEFT VENTRICULAR ASSIST DEVICE (LVAD). DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND THE ECG REVEALED ST SEGMENT ELEVATION (LEADS UNSPECIFIED). LEFT-SIDED CARDIAC CATHETERIZATION REVEALED CORONARY SPASM. IMPELLA LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS IMPLANTED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. THERE IS NO INFORMATION REGARDING PATIENT OUTCOME. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

  Patient problems: Low Blood Pressure/ Hypotension; Myocardial Infarction; No Code Available

  MAUDE report 6566980 ↗

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