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Class 2 Device Recall MicroVention Terumo HydroSoft 10, HydroSoft 3D |
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Date Initiated by Firm |
November 22, 2019 |
Create Date |
February 27, 2020 |
Recall Status1 |
Terminated 3 on January 26, 2022 |
Recall Number |
Z-1405-2020 |
Recall Event ID |
84727 |
510(K)Number |
K153594 K132952 K050954 K161367 K091641
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Product Classification |
Device, neurovascular embolization - Product Code HCG
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Product |
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV-00728HHTA, MV-00817HHTA, MV-00833HHTA, MV-01502HHTA, MV-01503HHTA, MV-01504HHTA, MV-02504HHTA, MV-02506HHTA, and MV-02508HHTA.
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: 100102HFRM-V - 1903045W6 and 1903135W6; 100152HFRM-V - 1903085W6, 1903185P6, and 1903185W6; 100153HFRM-V - 1903135W6; 100154HFRM-V - 1903015W6, 1903205W6, 1903225W6, 1904225P6, and 1904225W6; 100202HFRM-V - 1903065W6, 1903085W6, and 1903135W6; 100206HFRM-V - 1903065W6 and 1903085W6; 100208HFRM-V - 1903065W6; 100254HFRM-V - 1903045W6, 1903085W6, and 1903115W6; 100256HFRM-V - 1903045W6 and 1903225W6; 100308HFRM-V - 1903115W6, 1903155W6, and 1903205W6; MV-00202HHTA - 1903065Y6, 1903205Y6, and 1903225Y6; MV-00203HHTA - 1903085Y6, 1903225Y6, 1904155Y6, 1905085X6, 1905085Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00204HHTA - 1903085Y6, 1904155X6, 1904155Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905205Y6, and 1905225Y6; MV-00206HHTA - 1904015Y6, 1904155X6, 1905025Y6, 1905035Y6, 1905085Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00208HHTA - 1905135Y6, 1905205Y6, 1905225X6, and 1905225Y6; MV-00304HHTA - 1903065Y6, 1903135Y6, 1903205Y6, 1904035Y6, 1905025Y6, 1905065Y6, and 1905085Y6; MV-00306HHTA - 1903135Y6, 1903205Y6, 1903225Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1905025Y6, 1905035Y6, 1905085Y6, 1905105Y6, and 1905135Y6; MV-00308HHTA - 1905085Y6, 1905205Y6, and 1905225Y6; MV-00310HHTA - 1905025Y6, 1905035Y6, 1905065Y6, 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00408HHTA - 1903225X6, 1904035Y6, 1905025Y6, and 1905035Y6; MV-00412HHTA - 1903115Y6, 1903135Y6, 1903205Y6, 1904035Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1904225Y6, 1905025Y6, 1905035Y6, 1905065Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905175Y6, and 1905205Y6; MV-00510HHTA - 1903225Y6, 1904035Y6, 1904055Y6, 1905085Y6, 1905105Y6, 1905175Y6, and 1905225Y6; MV-00515HHTA - 1903225X6, 1904035Y6, 1905025Y6, 1905035Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905175X6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00612HHTA - 1903085Y6, 1903115Y6, 1903135Y6, 1903225X6, 1904055Y6, 1905025Y6, 1905035Y6, and 1905085Y6; MV-00619HHTA - 1903085Y6, 1903115Y6, 1903225Y6, 1904055Y6, 1905035Y6, 1905065Y6, 1905085Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00715HHTA - 1905065Y6, 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, 1905225X6, and 1905225Y6; MV-00728HHTA - 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00817HHTA - 1905105Y6, 1905175Y6, and 1905205X6; MV-00833HHTA - 1903085Y6, 1903205Y6, 1905035Y6, 1905085Y6, 1905135Y6, and 1905205Y6; MV-01502HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905105Y6, 1905175Y6, and 1905205Y6; MV-01503HHTA - 1903085Y6, 1903115Y6, 1903135Y6, 1903205Y6, 1903225X6, 1903225Y6, 1904035Y6, and 1905035Y6; MV-01504HHTA - 1905035Y6, 1905065Y6, and 1905085Y6; MV-02504HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905065Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-02506HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905065Y6, 1905105Y6, 1905135Y6, 1905205Y6, and 1905225Y6; and MV-02508HHTA - 1905085Y6, 1905105Y6, 1905135Y6, 1905155Y6, 1905205Y6, and 1905225Y6. |
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 |
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 |
847 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
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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 = HCG and Original Applicant = MICROVENTION, INC.
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