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.
- Company
- Biosense Webster, Inc.
- Recall Initiated
- February 25, 2015
- Posted
- March 3, 2015
- Terminated
- October 16, 2015
- Recall Number
- Z-1242-2015
- Quantity
- 464 units
- Firm Location
- Irwindale, CA
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.
Distribution
Nationwide Distribution
Lot / Code Info
All lots manufactured as of February 24, 2015 are affected.
Root Cause
Device Design
Action Taken
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.