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U.S. Department of Health and Human Services

Class 2 Device Recall MicroVention Terumo HydroFrame 10

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 Class 2 Device Recall MicroVention Terumo HydroFrame 10see related information
Date Initiated by FirmNovember 22, 2019
Create DateFebruary 27, 2020
Recall Status1 Terminated 3 on January 26, 2022
Recall NumberZ-1402-2020
Recall Event ID 84727
510(K)NumberK050954 K090357 K103758 K132952 K153594 K161367 
Product Classification Device, neurovascular embolization - Product Code HCG
ProductMicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HFRM-V, 100715HFRM-V, 100728HFRM-V, 100817HFRM-V, 100833HFRM-V, 100931HFRM-V; 101036HFRM-V, MV-00408HHFA, MV-00510HHFA, MV-00515HHFA, and MV-00619HHFA. 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.
Code Information Catalog/lot numbers:  100306HFRM-V - 1903135WF, 1903155WF, 1903015UF, 1903065UF, 1903065ZF, 1903085UF, 1903135UF, 1903155NF, 1903205UF, 1904015UF, 1904035UF, 1904155UF, 1904175UF, 1904225UF, 1904245UF, 1904265UF, 1905085UF, 1905105UF, 1905135UF, 1905155UF, and 1905175UF;  100405HFRM-V - 1903015WF, 1903085WF, 1904225PF, and 1905155WF;  100408HFRM-V - 1903015WF, 1903065WF, 1903085WF, 1903155WF, 1903225WF, 1904225PF, 1905155WF, 1903015UF, 1903135UF, 1903205UF, 1903225UF, 1904175UF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905025UF, 1905085UF, 1905135UF, and 1905155UF;  100410HFRM-V - 1903085WF and 1904055WF;  100412HFRM-V - 1903205UF, 1903225UF, 1904015UF, 1904035UF, 1904055UF, 1904155UF, 1904175UF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905155UF, 1905205UF, and 1905225UF;  100415HFRM-V - 1904105WF, 1904225PF, and 1905035WF;  100510HFRM-V - 1903015WF, 1903185WF, 1904175WF, 1905155WF, and 1905205RF;  100515HFRM-V - 1903015WF, 1903085WF, 1903185WF, 1904105WF, 1904175WF, 1904225PF, 1904225WF, 1904245WF, 1905085WF, 1903085UF, 1903135UF, 1903155UF, 1903205UF, 1903225UF, 1904015UF, 1904035UF, 1904055UF, 1904175UF, 1904175ZF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905085UF, 1905105UF, 1905135UF, 1905155UF, and 1905225UF;  100519HFRM-V - 1905155UF;  100612HFRM-V - 1903185WF, 1903225WF, and 1905205WF;  100619HFRM-V - 1903065WF, 1903185WF, 1903225WF, 1905155WF, 1903085UF, 1903155UF, 1903225UF, 1904155UF, 1904175UF, 1904225UF, and 1904245UF;  100623HFRM-V - 1903115UF;  100715HFRM-V - 1903045WF, 1903115WF, 1903135WF, 1903185WF, and 1903155QF;  100728HFRM-V - 1903015WF, 1903085WF, 1905155WF, and 1904225UF;  100817HFRM-V - 1903045WF, 1903135WF, and 1905155WF;  100833HFRM-V - 1903015WF, 1903045WF, 1903085WF, 1905155WF, 1905205WF, 1904055UF, and 1904225UF;  100931HFRM-V - 1903085WF, 1903185WF, 1904225PF, 1905155WF, 1903205UF, 1904015UF, 1904035UF, 1904265UF, and 1904295UF;  101036HFRM-V - 1903015WF, 1904225PF, 1905155WF, and 1904175UF;  MV-00408HHFA - 1905175YF;  MV-00510HHFA - 1905105YF;  MV-00515HHFA - 1905175YF and 1905205YF; and   MV-00619HHFA - 1905035YF and 1905175YF.
FEI Number 3003523199
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 Commerce991 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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