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U.S. Department of Health and Human Services

Class 2 Device Recall CARTO 3 System Interface Cable

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  Class 2 Device Recall CARTO 3 System Interface Cable see related information
Date Initiated by Firm October 05, 2010
Date Posted January 07, 2011
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-0884-2011
Recall Event ID 56986
510(K)Number k090017  
Product Classification Cable, transducer and electrode, patient, (including connector) - Product Code DSA
Product CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT
This product provides a signal interface between a Biosense Webster electrophysiology catheter and the appropriate equipment. This cable may be re-used subject to established cleaning and sterilization restrictions
Code Information Part Number: D-1286-18; Catalog Number CR3410CT
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
Manufacturer Reason
for Recall		 When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.
FDA Determined
Cause 2		 Device Design
Action Biosense Webster issued an Urgent Field Safety Notice letter dated October 5, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to return the affected cable, accompanied by the attached Return Authorization form. For questions regarding this recall call Biosense Webster at 909 839-8874.
Quantity in Commerce 1692
Distribution Worldwide Distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, and WV, and the countries of Belgium, China, Israel, Japan, Singapore, and Thailand.
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 = DSA and Original Applicant = BIOSENSE WEBSTER, INC.
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