Lassostar NAV D140403Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835020359), received between Apr 5, 2023 and Apr 5, 2023 — classified as 1 injury.

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

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.

• InjuryApr 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION CARDIAC ABLATION PROCEDURE WITH AN UNKNOWN LASSO DIAGNOSTIC CATHETER AND EXPERIENCED A PHRENIC NERVE PALSY. DEVICES USED DURING THE CASE: - CARTO3 SYSTEM (SN (B)(4) / V7.2.40.250), NGEN GENERATOR (SN (B)(4) ), NGEN PUMP (SN (B)(4) . THE CALLER CONFIRMED THAT NO OTHER BIOSENSE WEBSTER DEVICES HAVE BEEN USED. CATHETER USED DURING THE CASE: HELIOS STAR BALLOON, GUIDES STAR, AND LASSO STAR IT WAS REPORTED THAT ALL CATHETERS HAVE BEEN DISCARDED; THEREFORE, NO LOT NUMBERS COULD BE PROVIDED. THE BWI REPRESENTATIVE CONFIRMED THAT THEY DID NOT HAVE ANY ISSUE ON THE SYSTEM BUT IT WAS REPORTED THAT THE PATIENT HAD A PHRENIC NERVE PALSY DURING THE ABLATION OF THE RIGHT PULMONARY VEIN. THE PATIENT IS ALIVE. PROCEDURE HAS BEEN COMPLETED. NO DELAY.

  Patient problems: Paralysis

  MAUDE report 16680012 ↗