Recall Z-1223-2020 ยท KRD Device, Vascular, For Promoting Embolization
Microvention, Inc.
Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By:
| 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 | 392 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
| K151358 | AZUR CX Detachable 35 Coils MicroVention, Inc., Sep 25, 2015 |