MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V, 100825CSSR-V, 100837CSSR-V, 100933CSSR-V, and 101036CSSR-V. 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: 100202CSSR-V - 1903155ZC, 1903185UC, 1903225UC, 1904085UC, 1904225NC, 1905155ZC, 1905205UC, 1905205ZC, 1905225UC, 1903015WC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1905065WC, 1905085WC, 1905105WC, 1905175WC, 1905205WC, and 1905225WC; 100254CSSR-V - 1904105UC, 1904155UC, 1904175UC, 1904225ZC, 1904245UC, 1905025UC, 1905035UC, 1905065UC, 1905105UC, 1905135UC, 1905155UC, 1905175UC, 1905205UC, 1903015WC, 1904015WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, 1905175WC, and 1905225WC; 100306CSSR-V - 1903045UC, 1903065UC, 1903085UC, 1903115UC, 1903135UC, 1903155ZC, 1903185UC, 1903205UC, 1903225UC, 1904035RC, 1904105UC, 1904155UC, 1904175UC, 1904225UC, 1904245UC, 1904265UC, 1904295UC, 1905035UC, 1905065UC, 1905085UC, 1905105UC, 1905105ZC, 1905135UC, 1905155UC, 1905175UC, 1905205UC, 1905205ZC, 1905225UC, 1903015WC, 1903045WC, 1903065WC, 1903205WC, 1904015WC, 1904055WC, 1904085WC, 1904225PC, 1904225WC, 1904245WC, 1904245WH, 1904245WT, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905105WC, 1905155PC, and 1905205WC; 100408CSSR-V - 1903065UC, 1904015UC, 1904035RC, 1904035UC, 1904055UC, 1904055ZC, 1904085UC, 1903015WC, 1904015WC, 1904035WC, 1904155WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905155WC, and 1905175WC; 100412CSSR-V - 1903185UC, 1903205UC, 1903225UC, 1905085UC, 1905105ZC, 1905135UC, 1905225UC, 1903045WC, 1903085WC, 1903205WC, 1903225WC, 1904175PC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905155WC, 1905175WC, 1905205WC, and 1905225WC; 100515CSSR-V - 1903185UC, 1903205UC, 1904035RC, 1904155UC, 1904175UC, 1904225UC, 1904225ZC, 1904245UC, 1904265UC, 1905025UC, 1905035UC, 1905065UC, 1905085UC, 1905105UC, 1905135UC, 1905155UC, 1905205UC, 1905225UC, 1905225ZC, 1903015WC, 1903065WC, 1903085WC, 1903185WC, 1903205WC, 1904015WC, 1904035WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905225WC; 100522CSSR-V - 1904155UC, 1904175UC, 1904225UC, 1904245UC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904055WC, 1904175WC, 1904245WC, 1904265WC, 1904295WC, 1905035WC, 1905065WC, 1905155WC, 1905175WC, and 1905205WC; 100618CSSR-V - 1903205LC, 1905155LC, 1905205LC, 1905205VC, 1903045WC, 1903085WC, 1903185WC, 1904175WC, 1904225WC, 1904245WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905225WC; 100626CSSR-V - 1903015LC, 1903045WC, 1903065WC, 1903205WC, 1904015WC, 1904295WC, 1905065WC, 1905085WC, and 1905205WC; 100722CSSR-V - 1903015WC, 1903065WC, 1903185WC, 1904015WC, 1904175WC, 1904265WC, 1904295WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905175WC; 100731CSSR-V - 1903015WC, 1903045WC, 1903065WC, 1905085WC, 1905105WC, 1905155WC, and 1905205PC; 100825CSSR-V - 1903015WC, 1903045WC, 1904015WC, 1904105WC, 1904175PC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905085WC, 1905155PC, and 1905175WC; 100837CSSR-V - 1903015WC, 1903065WC, 1903085WC, 1904015WC, 1905105WC, 1905135WC, and 1905205WC; 100933CSSR-V - 1905135RC, 1903015WC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904265WC, 1905105WC, 1905175WC, and 1905225WC; and 101036CSSR-V - 1903015WC, 1903065WC, 1903085WC, 1903115WC, 1903205WC, 1905155WC, and 1905225WC.

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.