Microvention, Inc. recalls Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481…

Recall date

November 24, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1220-2020

FDA classification

Class II

Brand / firm

Microvention, Inc.

Sold / distributed

The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.

Why it was recalled

The devices may be missing the implant coil.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420, 45-480405, 45-480610, 45-480615, 45-480620, 45-480815, 45-480820, MV-AZ80520HL, MV-AZ80202HL, MV-AZ80204HL, MV-AZ80305HL, MV-AZ80310HL, MV-AZ80410HL, MV-AZ80420HL, MV-AZ80620HL, MV-AZ80820HL, and MV-AZ81020HL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.