Recall Z-0187-2024 ยท KRD Device, Vascular, For Promoting Embolization
MICROVENTION INC.
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
| Date | Oct 27, 2023 (initiated Aug 24, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151358 | AZUR CX Detachable 35 Coils MicroVention, Inc., Sep 25, 2015 |