Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endo
See all recalls from Microvention, Inc. →Recalled Product
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.
Hazard / Issue
The devices may be missing the implant coil.
Issued by
FDA
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.
Lot/Code Info: 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.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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