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Class 2 Device Recall Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil |
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Date Initiated by Firm |
November 24, 2019 |
Create Date |
February 13, 2020 |
Recall Status1 |
Terminated 3 on April 20, 2021 |
Recall Number |
Z-1224-2020 |
Recall Event ID |
84585 |
510(K)Number |
K151358
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Product Classification |
Device, Vascular, for Promoting Embolization - Product Code KRD
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Product |
Terumo 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
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For Additional Information Contact |
Dr. Irina Kulinets 714-247-8159
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Manufacturer Reason for Recall |
The devices may be missing the implant coil.
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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 |
19 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
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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.
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510(K) Database |
510(K)s with Product Code = KRD and Original Applicant = Micro Vention, Inc.
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