Class 2 Device Recall Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil

• Date Initiated by Firm: November 24, 2019
• Create Date: February 13, 2020
• Recall Status: Terminated on April 20, 2021
• Recall Number: Z-1222-2020
• Recall Event ID: 84585
• 510(K)Number: K120630
• Product Classification: Device, Vascular, for Promoting Embolization - Product Code KRD
• Product: Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
• Code Information: Catalog/lot numbers: 45-781032 - 1903065Z8,1903085Z8, 1903155Z8, 1903205Z8, 1903225Z8, 1904015Z8, 1904055Z8, 1904085Z8, 1904155Z8, 1904245Z8, 1904265Z8, 1904295Z8, and 1905155Z8; 45-781238 - 1903115Z8, 1903135Z8, 1903205Z8, 1904105Z8, 1904155Z8, 1904295Z8, and 1905065Z8; 45-781434 - 1903115Z8, 1903155Z8, 1904015Z8, 1904105Z8, 1904155Z8, and 1905155Z8; 45-781639 - 1903155Z8, 1903185Z8, and 1904015Z8; 45-781836 - 1903065Z8, 1903115Z8, 1903205Z8, 1903225Z8, 1904015Z8, 1904085Z8, 1904155Z8, and 1905155Z8; 45-782040 - 1903045Z8, 1903115Z8, 1903185Z8, 1904015Z8, 1904055Z8, 1904155Z8, 1905035ZA, 1905065Z8, 1905085Z8, and 1905155Z8; 45-780202 - 1903115Z8, 1903135Z8, 1903185Z8, 1904055Z8, 1904085Z8, 1904175ZA, 1904225Z8, 1904245Z8, 1904265Z8, 1904295Z8, 1905135Z8, and 1905205Z8; 45-780204 - 1903045Z8, 1903085Z8, 1903115Z8, 1903135Z8, 1904015Z8, 1904035Z8, 1904085Z8, 1904105Z8, 1904155Z8, 1904175Z8, 1904225Z8, 1904245Z8, 1904265Z8, 1904295Z8,1905025Z8, 1905035Z8, 1905065Z8, 1905085Z8, 1905105Z8, 1905105ZA, 1905135Z8, and 1905205Z8; 45-780304 - 1903085Z8, 1903115Z8, 1903135Z8, 1903135ZA, 1904035Z8, 1904035ZA, 1904175Z8, 1904175ZA, 1904225Z8, 1904245Z8, and 1904265Z8; 45-780308 - 1903015Z8, 1903045Z8, 1903115Z8, 1903135Z8, 1903155Z8, 1903185Z8, 1904055Z8, 1904105Z8, 1904155Z8, 1904175Z8, 1904225Z8, 1904245Z8, 1904265Z8, 1904295Z8, 1905035Z8, 1905065Z8, 1905085Z8, 1905135Z8, and 1905205Z8; 45-780413 - 1903015Z8, 1903045Z8,1903115Z8, 1903135Z8, 1903135ZA, 1903155Z8, 1904105Z8, 1904155Z8, 1904175Z8, 1904225Z8, 1904265Z8, 1904295Z8, 1905025Z8, 1905085Z8, 1905105Z8, 1905135Z8, and 1905205Z8; 45-780516 - 1903045Z8, 1903115Z8, 1903135Z8, 1903205Z8, 1904055Z8, 1904085Z8, 1904225Z8, 1904265Z8, 1904295Z8, 1905025ZA, 1905035Z8, 1905035ZA, 1905065Z8, 1905105Z8, 1905135Z8, and 1905205Z8; 45-780620 - 1903045Z8, 1903115Z8, 1903135Z8, 1903135ZA, 1903155Z8, 1903185Z8, 1904055Z8, 1904085Z8, 1904105Z8, 1904155Z8, 1904225Z8, 1904245Z8, 1904265Z8, 1904295Z8, 1905025Z8, 1905035Z8, 1905065Z8, 1905085Z8, 1905105Z8, 1905105ZA, 1905135Z8, and 1905205Z8; 45-780724 - 1903045Z8, 1903185Z8, 1904085Z8, 1904105Z8, 1904265Z8, 1904295Z8, 1905025Z8, 1905035Z8, 1905085Z8, and 1905135Z8; 45-780828 - 1903045Z8, 1903065Z8, 1903085Z8, 1903115Z8, 1903135Z8, 1903155Z8, 1903205Z8, 1903225Z8, 1904055Z8, 1904085Z8, 1904155Z8, 1904265Z8, 1904295Z8, 1905035Z8, 1905155Z8, and 1905155ZA; 45-780928 - 1903045Z8, 1903115Z8, 1904055Z8, 1904155Z8, and 1904295Z8; MV-AX80202CL - 1903015Y8 and 1904015Y8; MV-AX80204CL - 1903015Y8, 1903225Y8, 1904015Y8, and 1904035Y8; MV-AX80304CL - 1903205Y8, 1903225Y8, 1904055Y8, 1905035Y8, 1905065Y8, 1905065YA, 1905135Y8, 1905155Y8, 1905175Y8, and 1905205Y8; MV-AX80308CL - 1904015Y8, 1904035Y8, 1904055Y8, 1905065Y8, 1905085Y8, 1905135Y8, 1905155Y8, 1905205Y8, and 1905225Y8; MV-AX80413CL - 1903225Y8, 1904015Y8, 1904035Y8, 1905155Y8, 1905175Y8, and 1905205Y8; MV-AX80516CL - 1903015Y8, 1903225Y8, 1904015Y8, 1904035Y8, 1905175Y8, and 1905205Y8; MV-AX80620CL - 1903045Y8, 1903225Y8, 1904015Y8, 1905065Y8, 1905085Y8, 1905155Y8, 1905175Y8, and 1905205Y8; MV-AX80724CL - 1904015Y8, 1905155Y8, 1905175Y8, and 1905205Y8; MV-AX80828CL - 1903225Y8, 1904055Y8, 1905035YA, 1905065Y8, 1905085Y8, 1905155Y8, and 1905175Y8; MV-AX80928CL - 1904035Y8 and 1905065Y8; MV-AX81032CL - 1903015Y8, 1903045Y8, 1903225Y8, 1904015Y8, 1904055Y8, 1905035YA, 1905065Y8, 1905175Y8, and 1905205Y8; MV-AX81238CL - 1904015Y8, 1904035Y8, 1905035YA, and 1905175Y8; MV-AX81434CL - 1903045Y8, 1904015Y8, 1904035Y8, and 1905065Y8; MV-AX81639CL - 1903205Y8 and 1903225Y8; and MV-AX82040CL - 1905035YA, 1905065Y8, and 1905155Y8.
• Recalling Firm/ Manufacturer: Microvention, Inc.; 35 Enterprise; Aliso Viejo CA 92656-2601
• For Additional Information Contact: Dr. Irina Kulinets; 714-247-8159
• Manufacturer Reason for Recall: The devices may be missing the implant coil.
• FDA Determined Cause: Other
• Action: The recalling firm issued emails dated 11/24/2019 to the Terumo distributors and provided instructions for notification of their customers (physicians).
• Quantity in Commerce: 3,881 units
• Distribution: The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
• 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.

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