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U.S. Department of Health and Human Services

Class 1 Device Recall Coherex WaveCrest Left Atrial Appendage Occlusion System

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  Class 1 Device Recall Coherex WaveCrest Left Atrial Appendage Occlusion System see related information
Date Initiated by Firm May 07, 2018
Create Date August 30, 2018
Recall Status1 Terminated 3 on November 14, 2020
Recall Number Z-2878-2018
Recall Event ID 80720
Product Classification System, appendage closure, left atrial - Product Code NGV
Product WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Code Information All lots.
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
Manufacturer Reason
for Recall		 When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or failure to recapture the device.
FDA Determined
Cause 2		 Component design/selection
Action Coherex Medical notified customers via "URGENT FIELD SAFETY NOTICE Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System (32 mm) Catalog No: WCR1523, Lot Number: All" letter dated May 7, 2018. The letter provided an overview, and important information about the product description and codes, lots subject to removal, why customers were being contacted, What actions are required/instructions, available assistance/contact information, and Reply Form.
Quantity in Commerce 25 units
Distribution No U.S. Distribution. International Distribution only.
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.
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