FDA Medical Device Recalls (openFDA)
Biosense Webster, Inc.: 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
- Recall number
- Z-1617-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-06-19
- Posted
- 2013-06-28
- Terminated
- 2014-02-07
- Reason
- 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
- 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
- 10 units
- Distribution
- Distributed in the states of MN, FL, and UT.
- Lot, serial or model codes
- Lot # 15832314L
- 510(k) numbers
- ["K113213"]
- 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