Z-1223-2020Class II

Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers...

Name: Z-1223-2020 Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers...
Creator: Microvention, Inc.
Published: 2019-11-24
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2019-11-24 / Terminated

FDA source

Microvention, Inc. began a recall of Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230... on 2019-11-24. FDA classified it as Class II and gives the reason as "The devices may be missing the implant coil". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1223-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-24
Posted: 2020-02-13
Terminated: 2021-04-20
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 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: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Product code: KRD Device, Vascular, For Promoting Embolization
Reason for recall: The devices may be missing the implant coil.
FDA 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 in commerce: 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.
Product codes and lots: Catalog/lot numbers: 45-451015 - 190410589; 45-451020- 19030456J, 19041056C, 19041756Y, 190422549, and 190422573; 45-451215 -190410569; 45-451220 -19040853N; 45-451230 -19041554R; 45-451520 -19030654N, 190408565, 190410588, and 190422572; 45-451530 -19030456L, 190408569, 19041056A, 190415571, 19041756Z, 190417599, 19042656G, and 19050254X; 45-452020 -19030456N, 19030654L, 19030655W, 19040856A, and 19041552H; 45-452030 - 19041058A, 19041554U, and 19042656H; 45-450410 - 19030456C, 19030655V, 19041058F, and 190422575; 45-450415 - 190422574; 45-450405 - 19030453C, 19030456B, and 19042254B; 45-450610 - 19030456E, 19030654W, 190410568, and 19041058E; 45-450615 - 19030456F, 190401568, 19041058C, and 19041556Y; 45-450620 - 19030453J and 19030655N; 45-450815 - 19030456G, 19030654U, 19050253U, and 19050254Z; 45-450820 - 19030453K,19030456H, 19030654R, 19030655G, 19030655H, 19050253V, 19050254Y, 19050657T, and 19051058C; and MV-AZ52030HD - 190405564.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1223-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1220-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1221-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1222-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1223-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1224-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1225-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13

Product code KRD

K151358Class IIAZUR CX Detachable 35 CoilsMicroVention, Inc. / cleared 2015-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)