Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT Duo-Decapolar Electrophysiology Catheter has been designed for electrophysiological mapping of cardiac structures.
Recall
- Recall Number
- Z-3038-2011
- Event Number
- 59465
- Firm
- Biosense Webster, Inc.
- FEI Number
- 3003113629
- Product Code
- DRF
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- April 29, 2011
- Posted
- August 18, 2011
- Terminated
- October 12, 2012
- Address
- 15715 Arrow Hwy, Irwindale, CA, 91706-2006
Description
Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT Duo-Decapolar Electrophysiology Catheter has been designed for electrophysiological mapping of cardiac structures.
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 0128709, through the J&J Gateway (i.e., e-IFU websi
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.
Nationwide Distribution
1530 units