ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The affected catheter

FDA device recall Z-2664-2011 · posted 2011-06-27 · Terminated

Recall details

Recalling firm

Biosense Webster, Inc.

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.

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.

Root cause

Pending

Status

Terminated

Product code

DRF

Quantity affected

429 units (333 in US)

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore

Date initiated

2011-05-23

Date posted

2011-06-27

Date terminated

2012-10-12

Location

Irwindale, CA

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