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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System

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 Class 2 Device Recall Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization Systemsee related information
Date Initiated by FirmNovember 24, 2019
Create DateFebruary 13, 2020
Recall Status1 Terminated 3 on April 20, 2021
Recall NumberZ-1223-2020
Recall Event ID 84585
510(K)NumberK151358 
Product Classification Device, Vascular, for Promoting Embolization - Product Code KRD
ProductTerumo 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 By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Code Information 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.
Recalling Firm/
Manufacturer		 Microvention, Inc.
35 Enterprise
Aliso Viejo CA 92656-2601
For Additional Information ContactDr. Irina Kulinets
714-247-8159
Manufacturer Reason
for Recall		The devices may be missing the implant coil.
FDA Determined
Cause 2		Other
ActionThe recalling firm issued emails dated 11/24/2019 to the Terumo distributors and provided instructions for notification of their customers (physicians).
Quantity in Commerce392 units
DistributionThe devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KRD
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