Biosense Webster, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1617-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 19, 2013

Date Posted: July 10, 2013

Recall Number: Z-1617-2013

Event ID: 65506

Reason for Recall:

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.

Status: Terminated

Product Quantity: 10 units

Code Information:

Lot # 15832314L

Distribution Pattern:

Distributed in the states of MN, FL, and UT.

Voluntary or Mandated:

Voluntary: Firm initiated