CLASS II ONGOING Device recall · Reported 8 Nov 2023 · FDA Enforcement Report

AZUR CX 35 Peripheral Coil System Detachable recalled by Microvention

Microvention is recalling AZUR CX 35 Peripheral Coil System Detachable, distributed nationwide in the US. The recall was initiated on 24 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027

Quantity recalled14

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0187-2024
FDA event ID: 93147
Recalling firm: Microvention, Aliso Viejo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Aug 2023
FDA classified: 27 Oct 2023
Reported: 8 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

24 Aug 2023	Recall initiated by company
27 Oct 2023	Classified by FDA	+64 days
8 Nov 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Peripheral coil system detachable has a potential of unsealed pouch packaging.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.

Nationwide Arizona California Michigan Nevada New York Texas Virginia Washington

Questions about this recall

Why was it recalled?

Peripheral coil system detachable has a potential of unsealed pouch packaging.

Which lots are affected?

UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027

Where was it sold?

US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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