RegWardenFDA facility compliance records
Recall

Class II — MICROVENTION INC.

Recalling firmMicroVention Inc.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonPeripheral coil system detachable has a potential of unsealed pouch packaging.
ProductAZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Quantity14
DistributionUS Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Initiated2023-08-24
Classified2023-10-27
Recall numberZ-0187-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — MICROVENTION INC. (Z-0187-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93147/

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