Terumo AZUR CX Peripheral Coil System recall
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.
Why was Terumo AZUR CX Peripheral Coil System recalled?
The devices may be missing the implant coil.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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.
- Recalling firm
- Microvention, Inc.
- Quantity
- 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.
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)