Recall Z-1242-2015 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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
| Date | Mar 3, 2015 (initiated Feb 25, 2015) |
| Status | Terminated |
| 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 Volunta |
| Quantity | 464 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130602 | LASSO NAV DUO LOOP CATHETER Biosense Webster, Inc., Aug 14, 2013 |