Class 2 Device Recall AZURTM CX 35 Peripheral Coil System Detachable 13mm x 24 CM

• Date Initiated by Firm: August 24, 2023
• Date Posted: October 27, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0187-2024
• Recall Event ID: 93147
• 510(K)Number: K151358
• Product Classification: Device, Vascular, for Promoting Embolization - Product Code KRD
• Product: AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
• Code Information: UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027
• Recalling Firm/ Manufacturer: MICROVENTION INC.; 35 Enterprise; Aliso Viejo CA 92656
• For Additional Information Contact: Terrence Callahan; 949-899-7194
• Manufacturer Reason for Recall: Peripheral coil system detachable has a potential of unsealed pouch packaging.
• FDA Determined Cause: Process control
• Action: On 8/22/23, recall notices were mailed to customers, who were asked to do the following: 1) Stop using, quarantine, and return affected devices to the firm. 2) Complete and return the customer acknowledgement form via email to recalls@microvention.com. Inquires can be directed to customer service at 800-990-8368
• Quantity in Commerce: 14
• Distribution: US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
• 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.

• 510(K) Database: 510(K)s with Product Code = KRD