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U.S. Department of Health and Human Services

Class 3 Device Recall DuoDecapolar Electrophysiology Catheter

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  Class 3 Device Recall DuoDecapolar Electrophysiology Catheter see related information
Date Initiated by Firm April 29, 2011
Date Posted August 18, 2011
Recall Status1 Terminated 3 on October 12, 2012
Recall Number Z-3038-2011
Recall Event ID 59465
510(K)Number K953768  
Product Classification Catheter, electroderecording, or probe, electrode recording - Product Code DRF
Product 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.
Code Information Not available
Recalling Firm/
Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact
Manufacturer 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 0128709, through the J&J Gateway (i.e., e-IFU websi
FDA Determined
Cause 2
Labeling Change Control
Action 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.
Quantity in Commerce 1530 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRF and Original Applicant = CORDIS WEBSTER, INC.