Class 1 Device Recall Coherex WaveCrest Left Atrial Appendage Occlusion System

• Date Initiated by Firm: May 07, 2018
• Create Date: August 30, 2018
• Recall Status: Terminated 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.
• FEI Number: 3003113629
• 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: 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.