Recall Z-1617-2013
Biosense Webster, Inc. · initiated June 19, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Codes / lots: Lot # 15832314L
Reason for recall
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.
FDA-determined cause: Use error
Action taken
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.
Details
- Recall number
- Z-1617-2013
- Initiated
- June 19, 2013
- Posted by FDA
- June 28, 2013
- Terminated
- February 7, 2014
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Quantity
- 10 units
- Distribution
- Distributed in the states of MN, FL, and UT.
- Recalling firm
- Biosense Webster, Inc., Irwindale, CA