Reported Feb 19, 2020 · Terminated

Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015,…

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 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, 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
45-451015 - 190410589
45-451020- 19030456J
19041056C
19041756Y
190422549
and 190422573
45-451215 -190410569
45-451220 -19040853N
45-451230 -19041554R
45-451520 -19030654N
190408565
190410588
and 190422572
45-451530 -19030456L
190408569
19041056A
190415571
19041756Z
190417599
19042656G
and 19050254X
45-452020 -19030456N
19030654L
19030655W
19040856A
and 19041552H
45-452030 - 19041058A
19041554U
and 19042656H
45-450410 - 19030456C
19030655V
19041058F
and 190422575
45-450415 - 190422574
45-450405 - 19030453C
19030456B
and 19042254B
45-450610 - 19030456E
19030654W
190410568
and 19041058E
45-450615 - 19030456F
190401568
19041058C
and 19041556Y
45-450620 - 19030453J and 19030655N
45-450815 - 19030456G
19030654U
19050253U
and 19050254Z
45-450820 - 19030453K
19030456H
19030654R
19030655G
19030655H
19050253V
19050254Y
19050657T
and 19051058C
and MV-AZ52030HD - 190405564
Amount recalled: 392 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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