Agency classClass IIOur severity:High FDA (Devices)·Z-1222-2020·Announced 2020-02-19

Terumo AZUR CX Peripheral Coil System Recalled for Missing Implant Coil

Microvention, Inc. is recalling 3,881 units of the Terumo AZUR CX Peripheral Coil System because the devices may be missing the implant coil.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a missing critical component (implant coil) in a medical device, which poses a risk of harm if the device is used, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Microvention, Inc. is recalling 3,881 units of the Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil. The recall was initiated because the devices may be missing the implant coil. The devices are sterile and require a prescription (Rx).

The affected devices were distributed to Maryland in the United States. There was no direct military or government distribution. Foreign distribution was made directly to Belgium, Japan, Australia, Argentina, and Mexico. The devices were manufactured in Costa Rica and distributed by Terumo Medical Corporation.

Healthcare providers and patients should check their inventory and records for the specific reference numbers and lot numbers listed in the recall notice. If a device is found to be missing the implant coil, it should not be used. Users should contact Microvention, Inc. for further instructions on how to return or replace the affected units.

The recalled product

Product: Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL…
Manufacturer: Microvention, Inc.
Category: Medical Device — Neurovascular
Hazard: missing-component
Affected units: 3,881

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Catalog/lot numbers: 45-781032 - 1903065Z8
1903085Z8
1903155Z8
1903205Z8
1903225Z8
1904015Z8
1904055Z8
1904085Z8
1904155Z8
1904245Z8
1904265Z8
1904295Z8
and 1905155Z8
45-781238 - 1903115Z8
1903135Z8
1904105Z8
and 1905065Z8
45-781434 - 1903115Z8
45-781639 - 1903155Z8
1903185Z8

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 6 recalled by Microvention, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Microvention, Inc.

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Same hazard · missing component