Reported Feb 19, 2020 · Terminated

Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015,…

Microvention, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Microvention, Inc. · 35 Enterprise · Aliso Viejo, CA · 92656-2601

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 ByTerumo Medical Corporation, Somerset, NJ; Made in Costa Rica

Lot codes and dates: Catalog/lot numbers
45-481015 - 19031155A
45-481020 - 19031355E and 190424567
45-481215 - 19031154K and 19041554Z
45-481220 - 19051357G
45-481515 - 19041554W and 19041556Q
45-481520 - 19032053A
45-482020 - 190320539 and 19040855Y
45-482030 - 19040855X
45-480202 - 19032054J and 190506581
45-480204 - 19051357N
45-480310 - 19031154N
19031355G
190401554
and 19050657X
45-480302 - 19050657V and 19051357P
45-480305 - 19031154L
19031354G
19031355F
19042254K
19042453J
19050657W
and 19051357L
45-480410 - 19031154G
19031155B
19031354H
19031355H
19032054N
190415553
19042254L
and 19051357K
45-480415 - 19041554V and 19050657U
45-480420 - 190506582 and 19051357H
45-480405 - 190424568
45-480610 - 19041554Y
19041556V
and 19051357J
45-480615 - 19042254G
45-480620 - 19031354J
19041554X
and 19042453K
45-480815 - 19040853U and 190415552
45-480820 - 19031355J
19032053C
and 19032252U
MV-AZ80520HL - 190401556
190401566
and 19040554H
MV-AZ80202HL - 190517542 and 190517566
MV-AZ80204HL - 19051756C
MV-AZ80305HL - 190517543
MV-AZ80310HL - 190517544
MV-AZ80410HL - 19040554J and 19040555X
MV-AZ80420HL - 19050253Y
19050254W
190517545
and 190517569
MV-AZ80620HL - 19050254V and 190517546
MV-AZ80820HL - 19051756A
and MV-AZ81020HL - 190517564
Amount recalled: 445 units

The agency filed one notice per product. You are reading one of them; the other 5 are below.

The devices may be missing the implant coil.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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