Recall Z-1220-2020 ยท KRD Device, Vascular, For Promoting Embolization
Microvention, Inc.
Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420, 45-480405, 45-480610, 45-480615, 45-480620, 45-480815, 45-480820, MV-AZ80520HL, MV-AZ80202HL, MV-AZ80204HL, MV-AZ80305HL,
| 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 | 445 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 |