ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number D7R20P14CT The ISMUS Catheter with Auto ID Technology has been designed for electrophysiological mapping of cardiac structures.
- Company
- Biosense Webster, Inc.
- Recall Initiated
- April 29, 2011
- Posted
- August 18, 2011
- Terminated
- October 12, 2012
- Recall Number
- Z-3037-2011
- Quantity
- 325 units
- Firm Location
- Irwindale, CA
Reason for Recall
The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions for Use (e-IFU) for the "10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue", Catalog Number D128709, through the J&J Gateway (i.e., e-IFU websi
Distribution
Nationwide Distribution
Lot / Code Info
not available
Root Cause
Labeling Change Control
Action Taken
Biosense Webster sent an "URGENT FIELD SAFETY NOTICE" letter dated April 29, 2011 to all affected customers. The letter describes the product, problem, and the action taken by the firm. The letter notifies and advises customers that the updated IFUs for ISMUS Catheter with Auto ID Technology and the Duo-Decapolar catheters have been released and posted on the e-IFU website as of April 22, 2011 and April 21, 2011. Customers were instructed to complete the Acknowledgement Form and return the form to Biosense. Customers with questions or require additionial information were instructed to contact their Biosense Webster representative.