| Class 2 Device Recall THERMOCOOL SMARTTOUCH NAVIGATION Catheter | |
Date Initiated by Firm | October 19, 2014 |
Date Posted | October 27, 2014 |
Recall Status1 |
Terminated 3 on October 06, 2015 |
Recall Number | Z-0139-2015 |
Recall Event ID |
69532 |
PMA Number | P030031 P040036 |
Product Classification |
Cardiac ablation percutaneous catheter - Product Code LPB
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Product | ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603. |
Code Information |
Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010) |
Recalling Firm/ Manufacturer |
Biosense Webster, Inc. 15715 Arrow Hwy Irwindale CA 91706-2006
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For Additional Information Contact | 909-839-8500 |
Manufacturer Reason for Recall | The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. |
FDA Determined Cause 2 | Use error |
Action | A customer notification letter dated October 19, 2014, will be sent to all customers who purchased the Biosense Webster's ThermoCool SmartTouch Catheter Family. The letter informs the customers of the additional information for the safe and effective use of the ThermoCool SmartTouch Catheter, which will be included in the updated labeling. The letter informs the customers of the problems identified and the actions to be taken.
Customers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7am to 8pm EST. |
Quantity in Commerce | 173,329 units total (21,812 units in US) |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = LPB
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