Z-0187-2024Class II

AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

Name: Z-0187-2024 AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Creator: Microvention Inc.
Published: 2023-08-24
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2023-08-24 / Open, Classified / root cause: manufacturing process

FDA source

MICROVENTION INC. began a recall of AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 on 2023-08-24. FDA classified it as Class II and gives the reason as "Peripheral coil system detachable has a potential of unsealed pouch packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0187-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-24
Posted: 2023-10-27
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Product code: KRD Device, Vascular, For Promoting Embolization
Reason for recall: Peripheral coil system detachable has a potential of unsealed pouch packaging.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 8/22/23, recall notices were mailed to customers, who were asked to do the following: 1) Stop using, quarantine, and return affected devices to the firm. 2) Complete and return the customer acknowledgement form via email to [email protected]. Inquires can be directed to customer service at 800-990-8368
Quantity in commerce: 14
Distribution: US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Product codes and lots: UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0187-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0187-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-10-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)