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U.S. Department of Health and Human Services

Class 2 Device Recall MicroVention Terumo Microplex 18, Complex 18

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 Class 2 Device Recall MicroVention Terumo Microplex 18, Complex 18see related information
Date Initiated by FirmNovember 22, 2019
Create DateFebruary 27, 2020
Recall Status1 Terminated 3 on January 26, 2022
Recall NumberZ-1401-2020
Recall Event ID 84727
510(K)NumberK050954 K131948 K132952 K153594 
Product Classification Device, neurovascular embolization - Product Code HCG
ProductMicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.
Code Information Catalog/lot numbers:  180512CC-V - 1905205W3;  180820CC-V - 1903115L3;  181026CC-V - 1903115L3;   181434CC-V - 1903115L3, 1905155W3, and 1905205R3; and  182050CC-V - 1905205W3, 1903115L3, 1903115L3, 1903115L3, 1905155W3, and 1905205R3.   
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		Process design
ActionThe recalling firm issued letters beginning 11/22/2019 dated 11/26/2019 via email using different flags according to the region the foreign consignee was located, i.e. 'URGENT: FIELD SAFETY CORRECTION ACTION" (for EMEA), "URGENT: MEDICAL DEVICE RECALL" (for Japan), or "FIELD SAFETY ADVISORY NOTICE" (for Rest of World).
Quantity in Commerce19 units
DistributionAll distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
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 = HCG
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