Recall Z-1222-2020 ยท KRD Device, Vascular, For Promoting Embolization
Microvention, Inc.
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-AX8103
| Date | Nov 24, 2019 |
| Status | Terminated |
| Reason | The devices may be missing the implant coil. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120630 | AZUR DETACHABLE 18 MicroVention, Inc., Mar 28, 2012 |