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U.S. Department of Health and Human Services

Class 2 Device Recall THERMOCOOL SMARTTOUCH

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  Class 2 Device Recall THERMOCOOL SMARTTOUCH see related information
Date Initiated by Firm September 06, 2017
Create Date October 27, 2017
Recall Status1 Terminated 3 on November 19, 2019
Recall Number Z-0058-2018
Recall Event ID 78129
PMA Number P990071 P030031S025 P030031S034 
Product Classification Cardiac ablation percutaneous catheter - Product Code LPB
Product THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Code Information 17637495L 17638389L 17639706L 17639707L 17639708L 17640039L  17640494L  17640952L 17640040L  17640742L  17640953L 17640041L  17640743L  17640954L 17640490L  17640744L 17643130L 17638118L 17638387L 17638388L
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact Biosense Webster sales representative
866-473-7823
Manufacturer Reason
for Recall		 Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
FDA Determined
Cause 2		 Under Investigation by firm
Action All US and OUS customers, who have purchased the lots identified as part of this recall will be notified via customer letters in order to return the product to BWI facility where it will be segregated for further disposition. This product recall applies to hospitals (or direct customers) and distributors who have purchased and/or received the THERMOCOOL Catheters identified as part of this recall . One notification package which includes the Customer Notification Letter, Business Reply Form (B RF) and pre-paid return label will be distributed to the customers subject to this recall via a 3rd party vendor (Stericycle) for USA. OUS customer communication will occur in accordance with local regulations.
Quantity in Commerce 329 units
Distribution US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China
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.
PMA Database PMAs with Product Code = LPB and Original Applicant = BIOSENSE WEBSTER, INC.
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