FDA Medical Device Recalls (openFDA)
MICROVENTION INC.: AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
- Recall number
- Z-0187-2024
- Recalling firm
- MICROVENTION INC.
- Product
- AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
- Status
- Open, Classified
- Initiated
- 2023-08-24
- Posted
- 2023-10-27
- Terminated
- not on file
- Reason
- Peripheral coil system detachable has a potential of unsealed pouch packaging.
- 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 recalls@microvention.com. Inquires can be directed to customer service at 800-990-8368
- Quantity
- 14
- Distribution
- US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
- Lot, serial or model codes
- UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027
- 510(k) numbers
- ["K151358"]
- PMA numbers
- not on file
- Product code
- KRD
- Firm FEI
- 3013556777
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28