NaviStar RMT NR7TCS4YRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835008463), received between Jun 14, 2019 and Oct 29, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY THIS EVENT WAS ASSESSED AS A SERIOUS INJURY UNDER THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 10/1/2020 STATING THAT THE 4MM NON-IRRIGATED CATHETER WAS BEING USED FOR MAPPING. ABLATION WAS PERFORMED WITH THIS CATHETER FOR A FEW SECONDS ONLY. SINCE IT WAS CONFIRMED THAT ABLATION WAS PERFORMED FOR A FEW SECONDS WITH THE 4 MM CATHETER, ITS RELATIONSHIP WITH THE ADVERSE EVENT OCCURRENCE CANNOT BE EXCLUDED; THEREFORE, THIS EVENT IS ALSO NOW ASSESSED AS A SERIOUS INJURY UNDER THE 4MM NON-IRRIGATED CATHETER WITH THE AWARENESS DATE OF (B)(6) 2020. IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA/WOLFF-PARKINSON-WHITE SYNDROME (AVRT/WPW) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) AND CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)). DURING THE PROCEDURE, A 4MM NON-IRRIGATED CATHETER WAS BEING USED FOR MAPPING THE LEFT ATRIUM. ABLATION WAS DONE WITH THIS CATHETER FOR A FEW SECONDS ONLY; HOWEVER, THE PHYSICIAN NOT

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 10753301 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING NO MEDICAL OR SURGICAL INTERVENTION. DURING THE ABLATION PHASE, THE PATIENT SUDDENLY BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED BY ECHOCARDIOGRAM. NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED IN STABLE CONDITION AND REQUIRED FURTHER MONITORING. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. THERE¿S NO INFORMATION REGARDING PHYSICIAN CAUSALITY OPINION. NO BIOSENSE WEBSTER INC.(BWI) PRODUCT MALFUNCTIONS WERE REPORTED. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. AN UNKNOWN 8 FR SHORT SHEATH WAS USED DURING THE CASE. THE OVERALL TIME FOR ABLATION AT THE SITE OF THE INJURY WAS AROUND 2 MINUTES IN THE SLOW PATHWAY OF THE AVNRT. IT IS NOT CLEAR IF THE TAMPONADE HAPPENED DURING THE ABLATION OR DURING THE CATHETER MANIPULATION IN THE RIGHT ATRIUM. AN UNKNOWN GENERATOR WAS USED IN TEMPERATURE CONTROL MODE WITH POWER AT 30 WATTS AND A TEMPERATURE CUT-OFF AT 50 DEGREES. THE POWER DID NOT TITRATE DURING THE ABLATION. NO IMPEDANCE OR TEMPERATURE INCREASES WER

  Patient problems: Cardiac Tamponade

  MAUDE report 8701928 ↗

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