LASSO NAV D134904Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835009682), received between Dec 21, 2021 and Dec 21, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113213); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN (B)(6) FEMALE ((B)(6)) PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND A LASSO® NAV ECO CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A SEPTAL PUNCTURE WITH AN ACUNAV AND PERFORMED PULMONARY VEIN ISOLATION (PVI) WITH A LASSO CATHETER IN THE PULMONARY VEIN (PV), AND ABOUT 2 HOURS AFTER THE PROCEDURE WAS STARTED, THE EVENT OCCURRED. CAVO-TRICUSPID ISTHMUS (CTI) ABLATION WAS PERFORMED AFTER PVI WAS COMPLETED. BECAUSE THE BLOCK OF CTI WAS DIFFICULT, SL1 SHEATH WAS REPLACED WITH VIZIGO, AND ADDITIONAL ABLATION WAS PERFORMED. AFTER COMPLETION OF THE CTI BLOCK, BLOOD PRESSURE WAS CONFIRMED TO HAVE DECREASED WHILE CHECKING PVI. BECAUSE THE MOVEMENT OF THE CARDIAC SHADOW WAS POOR, ECHOCARDIOGRAPHY WAS PERFORMED, AND EFFUSION WAS CONFIRMED, SO PERICARDIOCENTESIS WAS PERFORMED FOR DRAINAGE. THE SYMPTOMS IMPROVED WITH DRAINAGE. THE PHYSICIAN COMMENTED THAT AS ARTERIAL BLOOD WAS DRAWN BY DRAINAGE, IT WAS THOUGHT TO HAVE OCCURRED DURING PVI, BUT IT WAS NOT CLEAR EXACTLY WHERE AND HOW THE TAMPONADE OCCURRED. ADDI

  Patient problems: Cardiac Tamponade

  MAUDE report 13050540 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113213. One submission often covers many models, so check the product and lot details in each record.

• Z-1617-2013 · Jun 19, 2013 · Terminated
  20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.