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U.S. Department of Health and Human Services

Class 2 Device Recall THERMOCOOL SMARTTOUCH SF BiDirectional Navigation Catheter

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  Class 2 Device Recall THERMOCOOL SMARTTOUCH SF BiDirectional Navigation Catheter see related information
Date Initiated by Firm September 07, 2022
Date Posted November 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-0169-2023
Recall Event ID 90887
PMA Number P030031 
Product Classification catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Product THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.
Code Information UDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L
Recalling Firm/
Manufacturer		 Johnson & Johnson Surgical Vision, Inc.
31 Technology Dr Ste 200
Irvine CA 92618-2302
Manufacturer Reason
for Recall		 Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.
FDA Determined
Cause 2		 Process control
Action On 09/07/2022, recall notices were mailed and emailed to customers requesting the following: 1) Ensure that anyone in your facility who needs to be aware of this notification reads the notice carefully. 2) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel. 3) Discard/Destroy the device as per your standard disposal process, ensuring it cannot be used. 4) Complete and return the business response form. Questions can be directed to the recalling firm representative. The following email address was provided: OneMD-Field-Actions@its.jnj.com
Quantity in Commerce 91
Distribution Worldwide - US Nationwide distribution in the states of NC, TN, VA, OH, MO, MI, GA, OR, MO, SD, CO, OH, FL, NJ, TX, IL, WI and the countries of CROATIA, GERMANY, HUNGARY.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = OAD and Original Applicant = BIOSENSE WEBSTER, INC.
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