FDA Device recall Z-1221-2020
Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. T…
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. T… by Microvention, citing the devices may be missing the implant coil.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1221-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-24 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Microvention |
| Distribution | MD |
Product
Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Reason
The devices may be missing the implant coil.
Identifiers
| code_info | Catalog/lot numbers: 45-681026 - 1903085J5,1903155J5, and 1904035J5; 45-681434 - 1903015J5,1903155J5, and 1904…Catalog/lot numbers: 45-681026 - 1903085J5,1903155J5, and 1904035J5; 45-681434 - 1903015J5,1903155J5, and 1904155J5; 45-682050 - 1903085K5, 1903135J5, 1903155J5, 1904015J5, 1904155J5, 1904175J5, and 1905105K5; and 45-680820 - 1903045J5, 1903085K5, 1903155J5, 1904015J5, 1904035J5, and 1904155J5. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1221-2020%22
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