Z-1402-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- November 22, 2019
- Termination Date
- January 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 991 units
Product Description
MicroVention 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.
Reason for Recall
The devices may be missing the implant coil.
Distribution Pattern
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.
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.