LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.
- Company
- Biosense Webster, Inc.
- Recall Initiated
- May 23, 2011
- Posted
- June 27, 2011
- Terminated
- October 12, 2012
- Recall Number
- Z-2666-2011
- Quantity
- 289 units (107 in US)
- Firm Location
- Irwindale, CA
Reason for Recall
The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore
Lot / Code Info
Catalog Numbers D7L2020CT
Root Cause
Pending
Action Taken
Biosense Webster, Inc. sent a Customer Notification Letter, dated May 24, 2011, with an Acknowledgement Form and Instructions for Manually Entering the Catheter Identification in the CARTO 3 System to all US and Outside US (OUS) customers who purchased these products. For customers in the US, two letters and forms will be sent via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. Instructions for manual entry of the catheter identification in the CARTO 3 System are being included in the communication to customers. These instructions will allow customers to input the identity of the catheter into the CARTO 3 System and be able to utilize the catheter. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. Customers were instructed to contact their BWI representative for any questions.