Microvention, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1407-2020)

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS-V, 100153HS-V, 100154HS-V, 100201HS-V, 100202HS-V, 100203HS-V, 100204HS-V, 100206HS-V, 100254HS-V, 100256HS-V, 100304HS-V, 100306HS-V, 100308HS-V, 100406HS-V, 100408HS-V, and 100508HS-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.

Class II

The devices may be missing the implant coil.

Catalog/lot numbers: 100101HS-V - 1903045UH, 1903065UH, 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1903225ZH, 1904085UH, 1904105UH, 1904175UH, 1904245UH, 1905025UH, 1905085UH, 1905105ZH, 1905135UH, 1905175UH, 1905205UH, 1905205ZH, 1905225UH, 1905225ZH, 1903135WH, 1904175WH, 1905085WH, 1905105PH, and 1905135WH; 100102HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1903225ZH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1905205ZH, 1905225UH, 1905225ZH, 1904035WH, and 1905155WH; 100103HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1904105UH, 1904155UH, 1904175UH, 1904225UH, 1904245UH, 1905025UH, 1905025ZH, 1905035UH, 1905035ZH, 1905065UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, and 1905085WH; 100104HS-V - 1903115UH, 1903135UH, 1903225UH, 1904085UH, 1904105UH, 1904155UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1904175WH, 1904225WH, and 1905155WH; 100151HS-V - 1905025UH, 1903135TH, 1903085WH, 1903205WH, 1904015WH, 1904265WH, 1904295WH, 1905085WH, 1905155WH, and 1905225PH; 100152HS-V - 1903155UH, 1903185UH, 1903205UH, 1904085UH, 1904105UH, 1904155UH, 1904225UH, 1904245UH, 1905025UH, 1905025ZH, 1905035UH, 1905035ZH, 1905065UH. 1905085UH, 1905105UH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205ZH, 1903065NH, 1904175TH, 1904225NH, 1905065NH, 1903015WH, 1903065WH, 1903185WH, 1904015WH, 1904035WH, 1904055WH, 1904085WH, 1904155WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, 1905065WH, 1905085WH, 1905155WH, and 1905225WH; 100153HS-V - 1903225UH, 1905105UH, 1905135UH, 1905135ZH, 1905155UH, 1905175UH, 1905205UH, 1905225UH, 1905225ZH, 1903015NH, 1903065WH, 1903085WH, 1903205WH, 1904015WH, 1904035WH, 1904055WH, 1904155WH, 1904175WH, 1904225PH, 1904225WH, 1904245WH, 1904265WH, 1905025WH, 1905035PH, 1905065WH, 1905085WH, 1905155WH, 1905205PH, 1905225PH, and 1905225WH. 100154HS-V - 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1905225UH, 1903115TH, 1903015WH, 1903045WH, 1903065WH, 1904035WH, 1904055WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905035PH, 1905035WH, 1905065WH, 1905085WH, 1905155PH, 1905155WH, 1905175WH, and 1905205WH; 100201HS-V - 1903135UH 100202HS-V - 1904085UH, 1904105UH, 1904175UH, 1904245UH, 1904225NH, 1905065NH, 1905205NH, 1903085WH, 1904015WH, 1904055WH, 1904175WH, 1904245WH, 1904265WH, 1904295WH, 1905085WH, 1905225PH, and 1905225WH; 100203HS-V - 1903155UH, 1903185UH, 1903225UH, 1904225NH, 1905135NH, 1903015WH, 1903065WH, 1904035WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905035WH, 1905155WH, and 1905225WH; 100204HS-V - 1904085UH, 1904105UH, 1904225UH, 1904245UH, 1905065UH, 1905085UH, 1905105UH, 1905135UH, 1905135ZH, 1905155UH, 1905175UH, 1905205UH, 1903045WH, 1903065WH, 1904015WH, 1904035WH, 1904155WH, 1904175WH, 1904225PH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035WH, 1905085WH, 1905155WH, and 1905225WH; 100206HS-V - 1904085UH, 1904105UH, 1904155UH, 1904175UH, 1904265UH, 1905065UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905175UH, 1905205UH 1905205ZH, 1905225UH, 1903065WH, 1903085WH, 1903185WH, 1904055WH, 1904175WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, 1905065WH, 1905155WH, 1905175WH, and 1905225WH; 100254HS-V - 1903205WH, 1904015WH, 1904225WH, 1904265WH, 1904295WH, 1905025WH, 1905085WH, and 1905225PH; 100256HS-V - 1903065WH, 1903185WH, 1904015WH, and 1905155WH; 100304HS-V - 1903085NH, 1903135TH, 1904035TH, 1903065WH, 1905035PH, and 1905065WH; 100306HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1904085UH, 1903065WH, 1904035WH, 1904055WH, 1904155WH, 1904175WH, 1904225WH, 1904245WH, 1905035PH, 1905065WH, 1905205PH, and 1905225PH; 100308HS-V - 1903185UH, 1903225UH, 1905135UH, 1905175UH, 1905205UH, 1903085NH, 1903015WH, 1903065WH, 1903185WH, 1904015WH, 1904035WH, 1904055WH, 1904175WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, and 1905065WH; 100406HS-V - 1903085WH, 1903185WH, 1904035WH, 1904225WH, and 1905205WH; 100408HS-V - 1905085UH, 1905105UH, 1905135UH, 1905155UH, 1903115TH, 1903015WH, 1903065WH, 1904265WH, 1904295WH, 1905085WH, 1905135WH, 1905155WH, and 1905205PH; 100508HS-V - 1903225TH, 1905205NH, 1903015WH, 1903085WH, 1903135WH, 1903185WH, 1904265WH, 1905105WH, and 1905205WH.

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.

Voluntary: Firm initiated