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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil 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-1221-2020
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, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, 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:   45-681026 - 1903085J5,1903155J5, and 1904035J5;   45-681434 - 1903015J5,1903155J5, and 1904155J5;   45-682050 - 1903085K5, 1903135J5, 1903155J5, 1904015J5, 1904155J5, 1904175J5, and 1905105K5; and   45-680820 - 1903045J5, 1903085K5, 1903155J5, 1904015J5, 1904035J5, and 1904155J5.
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 107 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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