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U.S. Department of Health and Human Services

Class 2 Device Recall LASSO 2515 Variable Circular Mapping Catheter

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  Class 2 Device Recall LASSO 2515 Variable Circular Mapping Catheter see related information
Date Initiated by Firm March 25, 2008
Date Posted August 25, 2008
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-1704-2008
Recall Event ID 47522
510(K)Number K031161  
Product Classification Circular Mapping Catheter - Product Code DRF
Product Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording and stimulation only. The device is designed to obtain electrograms in the atrial regions of the heart.

20 Poles, US Catalog Number D7L202515RT, EU Catalog Number 35T2515R
Code Information All lots
Recalling Firm/
Manufacturer		 Biosense Webster Inc
3333 S Diamond Canyon Rd
Diamond Bar CA 91765-4701
For Additional Information Contact Diana M. Thorson
909-839-8604
Manufacturer Reason
for Recall		 This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and sep
FDA Determined
Cause 2		 Device Design
Action A letter entitled, "Urgent Safety Field Notice" dated March 25, 2008, and certification form were sent to all customers and Johnson & Johnson affiliates who purchased the product in the past year as of March 25, 2008, due to the expiration date. For customers in the US, two letters and forms were sent out - one addressed to the EP/Cardiology Lab and a second to the Risk Management Office. If you have questions or have not received a letter contact Customer Service at 1-800-729-9010.
Quantity in Commerce 14,295 units for both products
Distribution Nationwide and Worldwide to: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary , Iran, Ireland, Isra¿¿l, Italy, Japan, Lithuania, Luxembourg, Mexico, Middle East, Netherlands, Norway, Panama, Poland, Portugal, Russia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
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 = BIOSENSE WEBSTER, INC.
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