MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V, 100256HS3D-V, 100304HS3D-V, 100306HS3D-V, 100310HS3D-V, 100355HS3D-V, 100358HS3D-V, 100406HS3D-V, 100408HS3D-V, 100412HS3D-V, 100415HS3D-V, 100510HS3D-V, 100515HS3D-V; MV-00102HTDA, MV-00103HTDA, MV-00204HTDA,MV-00304HTDA, MV-00306HTDA, MV-00406HTDA, MV-00408HTDA, MV-00510HTDA, MV-01502HTDA, MV-01503HTDA, MV-01504HTDA; MV-02504HTDA, MV-02506HTDA, MV-03505HTDA, and MV-03508HTDA. 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.

Reason: The devices may be missing the implant coil.

Code information: Catalog/lot numbers: 100102HS3D-V - 1903045WT, 1903065WT, 1903205WT, 1904015WT, 1904035WT, 1904245WT, 1904255WT, 1904265WT, 1904295WT, 1905025WT, 1905065WT, 1905085WT, 1905155WT, 1905175WT, and 1905205WT; 100103HS3D-V - 1903115TT, 1903015WT, 1903085WT, 1903135WT, 1904015WT, 1904035WT, 1904055WT, 1904105WT, 1904265WT, 1904295WT, 1905035WT, 1905105PT, 1905135WT, 1905155WT, and 1905225WT; 100152HS3D-V - 1903065NT, 1903045WT, 1903085WT, 1903205WT, 1903225WT, 1904015WT, 1904105WT, 1904175WT, 1904295WT, 1905025WT, 1905105WT, 1905135WT, 1905155WT, and 1905175WT; 100153HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903155WT, 1904015WT, 1904035WT, 1904265WT, 1904295WT, 1905135WT, and 1905205WT; 100154HS3D-V - 1903045WT, 1903085WT, 1903135WT, 1903185WT, 1903225WT, 1904015WT, 1904035WT, 1904085WT, 1904105WT, 1904155WT, 1904175WT, 1904225WT, 1905025WT, 1905135WT, 1905155PT, 1905155WT, 1905175WT, and 1905205WT; 100202HS3D-V - 1903015WT, 1903065WT, 1903185WT, 1903205WT, 1905105WT, and 1905205WT; 100203HS3D-V - 1904015WT, 1904035WT, 1904265WT, 1904295WT, 1905065WT, 1905085WT, 1905155WT, and 1905225PT; 100204HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903085WT, 1904035WT, 1904055WT, 1904085WT, 1904245WT, 1904255WT, 1904295WT, 1905035WT, 1905065WT, and 1905085WT; 100206HS3D-V - 1904175WT, 1904225WT, 1904245WT, 1905105WT, 1905155PT, and 1905155WT; 100208HS3D-V - 1903085WT, 1903155WT, 1904035WT, 1905155PT, and 1905155WT; 100254HS3D-V - 1903015WT, 1903065WT, 1904015WT, 1904035WT, 1904055WT, 1904155WT, 1904225WT, 1904245WT, 1905035PT, 1905065WT; 100256HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903085WT, 1904015WC, 1904015WT, 1904035WT, 1904175WT, 1904245WT, 1904255WT, 1904265WT, 1904295WT, 1905035WH, 1905035WT, 1905155PT, and 1905225WT; 100304HS3D-V - 1903065WT, 1903115WT, 1903155WT, 1903205WT, 1904015WT, 1904055WT, 1904255WT, 1905105WT, 1905175WT, and 1905205WT; 100306HS3D-V - 1903085NT, 1903015WT, 1903085WT, 1903115WT, 1903135WT, 1903155WT, 1904015WT, 1904035WT, 1904055WT, 1904085WT, 1904225PT, 1904225WT, 1904245WT, 1904255WT, 1904265WT, 1905135WT, 1905175WT, and 1905205WT; 100310HS3D-V - 1903085WT and 1904035WT; 100355HS3D-V - 1903045WT, 1903085WT, 1904015WT, 1904225PT, 1904225WT, and 1905175WT; 100358HS3D-V - 1903065WT, 1904255WT, 1904265WT, 1904295WT, 1905035WT, 1905065WT, 1905085WT, 1905155WT, and 1905175WT; 100406HS3D-V - 1903015WT, 1903115WT, 1903205WT, 1904015WT, and 1905205WT; 100408HS3D-V - 1905205NT,1903085WT, 1903205WT, 1904015WT, 1904035WT, 1904055WT, 1904175WT, 1904225PT, 1904225WT, 1904255WT, 1904265WT, 1904295WT, 1905025WT, 1905105WT, 1905155WT, and 1905175WT; 100412HS3D-V - 1903135WT, 1904035WT, 1904175WT, and 1905105WT; 100415HS3D-V - 1903135WT, 1904035WT, 1905105WT, and 1905155WT; 100510HS3D-V - 1903065WT, 1904015WT, 1904035WT, 1904245WT, 1905105WT, and 1905155WT; 100515HS3D-V - 1903085NT, 1903015WT, 1903045WT, 1903085WT, 1903185WT, 1903205WT, 1904015WT, 1904035WT, 1904175WT, 1904265WT, 1904295WT, 1905025WT, 1905035WT, 1905085WT, 1905175WT; MV-00102HTDA - 1903015YT, 1903045YT, 1903155XT, 1904105YT, and 1904155XT; MV-00103HTDA - 1903045YT, 1903185YT, 1905065YT, and 1905085YT; MV-00204HTDA - 1904085YT and 1905065YT; MV-00304HTDA - 1905085YT; MV-00306HTDA - 1903015YT, 1903155XT, and 1903155YT; MV-00406HTDA - 1903015YT, 1904055YT, 1905065YT, and 1905085YT; MV-00408HTDA - 1903155YT, 1904015XT, 1904085YT, 1905035XT, 1905065YT, and 1905085YT; MV-00510HTDA - 1904085YT and 1905085YT; MV-01502HTDA - 1903015YT, 1904085YT, 1904105YT, 1905085YT, and 1905105YT; MV-01503HTDA - 1904055YT, 1904085YT, 1905085YT, 1905105XT, and 1905135YT; MV-01504HTDA - 1904085YT, 1904105YT, 1905085YT, 1905105XT, 1905105YT, 1905135YT, and 1905155YT; MV-02504HTDA - 1903155YT, 1904055YT, and 1905085YT; MV-02506HTDA - 1903155YT, 1905085YT, and 1905105YT; and MV-03505HTDA - 1903015YT, 1903155YT, 1904085YT, 1905085YT, and 1905105YT; and MV-03508HTDA - 1904055YT, 1904085YT, 1905085YT, and 1905105XT.

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.