Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

20-Pole LASSO Nav Catheter Eco Recalled by Biosense Webster, Inc. Due to Biosense Webster is recalling the 20-Pole LASSO NAV...

Date: June 19, 2013
Company: Biosense Webster, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biosense Webster, Inc. directly.

Affected Products

20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.

Quantity: 10 units

Why Was This Recalled?

Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.

Where Was This Sold?

This product was distributed to 3 states: FL, MN, UT

Affected (3 states)Not affected

About Biosense Webster, Inc.

Biosense Webster, Inc. has 31 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report