FDA Medical Device Recalls (openFDA)
Biosense Webster, Inc.: 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.
- Recall number
- Z-1242-2015
- 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.
- Status
- Terminated
- Initiated
- 2015-02-25
- Posted
- 2015-03-03
- Terminated
- 2015-10-16
- Reason
- 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
- 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
- 464 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- All lots manufactured as of February 24, 2015 are affected.
- 510(k) numbers
- ["K130602"]
- PMA numbers
- not on file
- Product code
- DRF
- Firm FEI
- 3003113629
- Firm city
- Irwindale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28