medical Class II Updated 2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Embolization Coil

Recalled Product

MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-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: 180619CS-V - 1903065W1, 1904015P1, 1904225W1, 1904295W1, 1905085P1, 1905085W1, 1905175W1, and 1905205W1; 180723CS-V - 1903085W1, 1903185W1, 1904015P1, 1904175P1, 1904295W1, 1905085W1, and 1905175W1; 180827CS-V - 1903205W1, 1904015P1, 1905155W1, and 1905205W1; 180931CS-V - 1904225R1, 1903205W1, 1905175W1, and 1905225W1; 181036CS-V - 1904035R1, 1903085W1, 1903185W1, 1904225W1, 1904265W1, 1905035W1, 1905065W1, 1905175W1, and 1905205W1; 181139CS-V - 1903015L1, 1903015W1, 1903085P1, 1903085W1, 1903185W1, 1904015P1, 1904245P1, and 1904245W1; 181243CS-V - 1903015L1, 1903015W1, 1903065W1, 1903185W1, 1904015P1, 1904175P1, 1904225W1, 1904265W1, 1904295W1, 1905155W1, 1905175W1, and 1905225W1; 181347CS-V - 1903085V1, 1903135R1, 1904035R1, 1903015W1, 1903085W1, 1903205P1, 1903205W1, and 1904225W1; 181451CS-V - 1903085W1, 1903225W1, 1904015P1, 1904175P1, 1904225W1, 1904295W1, 1905105W1, and 1905135W1; 181652CS-V - 1905135R1, 1903015W1, 1903045W1, 1903085W1, 1903205W1, 1903225W1, 1904105W1, 1905105W1, and 1905225W1; 181859CS-V - 1903155P1, 1903155W1, 1903185H1, and 1905105W1; 182065CS-V - 1903045L1, 1904085Q1, 1903155W1, 1903185H1, and 1903205H1; 182263CS-V - 1904035R1; and 182468CS-V - 1903015L1, 1903135R1, 1904055R1, 1905205R1, 1904295H1, 1905025G1, 1905025H1, 1905105H1, 1905105W1, 1905135H1, and 1905205H1.
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