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 NA
FDA device recall Z-1242-2015 · posted 2015-03-03 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DRF
- Quantity affected
- 464 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-02-25
- Date posted
- 2015-03-03
- Date terminated
- 2015-10-16
- Location
- Irwindale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LASSO NAV DUO LOOP CATHETER (K130602) | Biosense Webster, Inc. | 2013-08-14 |