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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil

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 Class 2 Device Recall Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coilsee related information
Date Initiated by FirmNovember 24, 2019
Create DateFebruary 13, 2020
Recall Status1 Terminated 3 on April 20, 2021
Recall NumberZ-1224-2020
Recall Event ID 84585
510(K)NumberK151358 
Product Classification Device, Vascular, for Promoting Embolization - Product Code KRD
ProductTerumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, 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:   45-651026 - 19030655Y, 19041556W, and 19051058A; and   45-652050 - 19030654Y and 19041556X. 
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 Commerce19 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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