Z-1617-2013Class II

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

Name: Z-1617-2013 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of...
Creator: Biosense Webster, Inc.
Published: 2013-06-19
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2013-06-19 / Terminated / root cause: manufacturing process

FDA source

Biosense Webster, Inc. began a recall of 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart on 2013-06-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1617-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-19
Posted: 2013-06-28
Terminated: 2014-02-07
Recalling firm: Biosense Webster Inc
Product: 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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.
Root cause tag: manufacturing process
FDA root cause: Use error
Action: An Urgent Field Notice letter was sent to all their customers who purchased the 20-Pole LASSO NAV Catheter Eco. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to complete and return the attached Voluntary Field Removal Certification Form in accordance with the instructions listed on the form. Customers are instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Monday-Friday from 7:00AM to 8:00 PM EST if they have any questions. For questions related to the Voluntary Field Removal Certification Form and its return, customers are instructed to contact the Field Action Coordinator, at (909) 839-8468.
Quantity in commerce: 10 units
Distribution: Distributed in the states of MN, FL, and UT.
Product codes and lots: Lot # 15832314L

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1617-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1617-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-06-28

Product code DRF

K113213Class IILasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued from Line 2Biosense Webster, Inc. / cleared 2011-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)