Z-1242-2015Class II

LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05...

Name: Z-1242-2015 LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05...
Creator: Biosense Webster, Inc.
Published: 2015-02-25
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2015-02-25 / Terminated / root cause: design

FDA source

Biosense Webster, Inc. began a recall of LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated... on 2015-02-25. FDA classified it as Class II and gives the reason as "Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1242-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-25
Posted: 2015-03-03
Terminated: 2015-10-16
Recalling firm: Biosense Webster Inc
Product: LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
Root cause tag: design
FDA root cause: Device Design
Action: Biosense Webster sent an Urgent Voluntary Medical Device Recall letter dated February 24, 2015 , to all affected customers. The letter informed customers that Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. The letter informed the customers of the problems identified and the actions to be taken. Customers with questions were instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Monday through Friday from 7am to 8pm EST. Customers with questions related to the Voluntary Field Removal Certification Form and its return, are instructed to call (909) 839-8468. For questions regarding this recall call 909-839-8500.
Quantity in commerce: 464 units
Distribution: Nationwide Distribution
Product codes and lots: All lots manufactured as of February 24, 2015 are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1242-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1242-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-03

Product code DRF

K130602Class IILasso Nav Duo Loop CatheterBiosense Webster, Inc. / cleared 2013-08-14

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)