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U.S. Department of Health and Human Services

Class 2 Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology,

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  Class 2 Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology, see related information
Date Initiated by Firm May 23, 2011
Date Posted June 27, 2011
Recall Status1 Terminated 3 on October 12, 2012
Recall Number Z-2664-2011
Recall Event ID 58884
510(K)Number K953768  
Product Classification Catheter, electrode recording, or probe, electrode recording - Product Code DRF
Product ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog #
D7R20P14CT

The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.
Code Information Catalog # D7R20P14CT
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact
909-839-8604
Manufacturer 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.
FDA Determined
Cause 2		 Pending
Action 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.
Quantity in Commerce 429 units (333 in US)
Distribution Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore
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.
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