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.
FDA Recall Z-3038-2011 · Posted 2011-08-18
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Recalling FirmBiosense Webster, Inc.
Recall StatusTerminated
Product CodeDRF
Date Initiated2011-04-29
Date Terminated2012-10-12
Product Quantity1530 units
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
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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