NaviStar RMT NR7TCS4YURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835008470), received between Jun 21, 2019 and Feb 13, 2026 — classified as 1 death, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT(ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION WITH A NAVISTAR CATHETER AND THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED A TEMPORARY PACEMAKER. IT WAS REPORTED THAT WHILE ABLATING NEAR THE AV (ATRIOVENTRICULAR) NODE, THE PATIENT WENT INTO HEART BLOCK. PRIOR TO COMING ON ABLATION, NO HIS SIGNALS WERE SEEN ON THE INTRACARDIAC ELECTROGRAMS. WHEN ABLATION WAS APPLIED AT 40 WATTS, THE PATIENT'S ATRIUM AND VENTRICLE WERE DISASSOCIATED WITH EACH OTHER. THE PHYSICIAN PUT IN A TEMPORARY PACER AT THE TIME. THE PATIENT WAS REPORTED TO BE STABLE AND WAS BEING OBSERVED TO SEE IF THEIR NODE RECOVERS. THE MEDICAL TEAM REPORTED TO HAVE ALWAYS HAD SIGNALS ON THE CATHETER, BUT THAT THEY DID NOT SEE A HIS SIGNAL. THEY CLAIMED THAT THIS DID NOT MEAN THE CATHETER WAS FAULTY BUT THAT THEY SIMPLY DID NOT BURN THE HIS. AFTER THE ABLATION THE PATIENT HAD COMPLETE HEART BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED. THE DOCTOR DID NOT BLAME THE CATHETER OR THE MAPPING SYSTEM.

  Patient problems: Heart Block

  MAUDE report 24334397 ↗
• InjuryFeb 11, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT ((B)(6) LBS) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER ON (B)(6) 2021 AND SUFFERED CEREBROVASCULAR ACCIDENT (CVA) REQUIRING PROLONGED HOSPITALIZATION. NO BWI PRODUCT MALFUNCTIONS NOR IMMEDIATE PATIENT CONSEQUENCES FROM THE ABLATION PROCEDURE WERE REPORTED. MAX WATTAGE USED WAS 35 WATTS. ON (B)(6) 2021, THE CLINICAL ACCOUNT SPECIALIST (CAS) THAT SUPPORTED THE CASE, WAS MADE AWARE THAT POST-PROCEDURE, THE PATIENT DEVELOPED VISUAL ANOMALIES (LOSS OF RIGHT VISUAL FIELD) AND CVA WAS CONFIRMED. THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT (ICU) AND REQUIRED PROLONGED HOSPITALIZATION. THERE¿S NO INFORMATION REGARDING MEDICAL/SURGICAL INTERVENTIONS. PHYSICIAN CAUSALITY OPINION IS UNKNOWN. THE PATIENT IS CURRENTLY IN SOME FORM OF OUTPATIENT REHABILITATION FOR HIS VISUAL CHANGES. NO FURTHER INFORMATION IS AVAILABLE. SINCE THIS EVENT IS LIFE THREATENING AND REQUIRED PROLONGED HOSPITALIZATION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

  Patient problems: Stroke/CVA

  MAUDE report 11317823 ↗
• DeathJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT ((B)(6) LB) UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE UNDER GENERAL ANESTHESIA USING STEREOTAXIS AND A NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC ARREST, HEART FAILURE AND DEATH. PATIENT WAS NOTED TO HAVE A RAPID HEART RATE THOUGHT TO BE RELATED TO ATRIAL ARRHYTHMIA. PLAN WAS FOR AN AV NODE ABLATION AND PLACEMENT OF A BI-VENTRICULAR PACEMAKER. PRIOR TO PLANNED PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD IN FACT A SLOW VENTRICULAR TACHYCARDIA WITH MORE VENTRICULAR ELECTROGRAMS THAN ATRIAL ELECTROGRAMS. AFTER UNDERGOING ANESTHESIA, THE PATIENT CONVERTED TO SINUS RHYTHM. DECISION WAS MADE TO PERFORM A BIPOLAR MAP OF THE LV TO LOOK FOR REGIONS OF SCAR. THERE WERE NO NOTED LOW VOLTAGE REGIONS. AREAS OF DOUBLE POTENTIALS WERE TARGETED. A SMALL NUMBER OF LESIONS WERE PLACED (APPROXIMATELY 10-15) AND THERE WAS NO EVIDENCE OF IMPEDANCE RISE OR PRODUCT MALFUNCTION. TEMPERATURE WAS SET AT 45 DEGREES CELSIUS. PROCEDURE WAS COMPLETED, AND PATIENT WAS AWAKENING FROM ANESTHESIA. ABOUT ONE HOUR AFTER THE CASE WAS COMPLETED, THE PATIENT CODED, AND THE BLOOD PRESSURE DROPPED. BEDSIDE ECHOCARDIOGRAM DID NO

  Patient problems: Cardiac Arrest; Death; Heart Failure

  MAUDE report 8725234 ↗

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