Microvention, Inc. recalls Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coi

Hazard / Issue

The devices may be missing the implant coil.

Issued by

FDA

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.

Lot/Code Info: 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.