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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo AZUR Peripheral Coil System, Detachable 18

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  Class 2 Device Recall Terumo AZUR Peripheral Coil System, Detachable 18 see related information
Date Initiated by Firm November 24, 2019
Create Date February 13, 2020
Recall Status1 Terminated 3 on April 20, 2021
Recall Number Z-1220-2020
Recall Event ID 84585
510(K)Number K120630  
Product Classification Device, Vascular, for Promoting Embolization - Product Code KRD
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.
Code Information 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.                                
Recalling Firm/
Manufacturer		 Microvention, Inc.
35 Enterprise
Aliso Viejo CA 92656-2601
For Additional Information Contact Dr. Irina Kulinets
714-247-8159
Manufacturer Reason
for Recall		 The devices may be missing the implant coil.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KRD and Original Applicant = MICRO VENTION, INC.
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