Microvention, Inc.: 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.

Recall number

Z-1220-2020

Recalling firm

Microvention, Inc.

Product

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.

Status

Terminated

Initiated

2019-11-24

Posted

not on file

Terminated

2021-04-20

Reason

The devices may be missing the implant coil.

Root cause

Other

Action

The recalling firm issued emails dated 11/24/2019 to the Terumo distributors and provided instructions for notification of their customers (physicians).

Quantity

445 units

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

["K120630"]

PMA numbers

not on file

Product code

KRD

Firm FEI

3003523199

Firm city

Aliso Viejo

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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