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U.S. Department of Health and Human Services

Class 2 Device Recall MicroVention Terumo HydroFrame 18

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  Class 2 Device Recall MicroVention Terumo HydroFrame 18 see related information
Date Initiated by Firm November 22, 2019
Create Date February 27, 2020
Recall Status1 Terminated 3 on January 26, 2022
Recall Number Z-1403-2020
Recall Event ID 84727
510(K)Number K153594  K132952  K050954  K161367  K090357  
Product Classification Device, neurovascular embolization - Product Code HCG
Product MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA.

Product Usage: The HES 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:  180723HFRM-V - 1904175P7 and 1904175W7;  180931HFRM-V - 1904225P7 and 1904225W7;  181644HFRM-V - 1905025W7 and 1905155W7;  MV-80619HHFA - 1904175X7, 1904175Y7,1905065X7, and 1905085Y7;  MV-80827HHFA - 1904175X7, 1904225Y7, and 1905065X7;  MV-80931HHFA - 1905065X7; and  MV-81036HHFA - 1904175Y7. 
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		 Process design
Action The 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 Commerce 32 units
Distribution All 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 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 = HCG and Original Applicant = MICROVENTION, INC.
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