MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-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: 100206HCSR-S-V - 1903225UH, 1904055UH, 1904085UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905225UH, 1903015WL, 1903205WL, 1904295WL, 1905035WL, and 1905175PL; 100208HC-S-V - 1904035RL, 1904155LL, 1905035LL, 1905065LL, and 1905065VL 100208HCSR-S-V - 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1903085RL, 1903015WL, and 1903065WL; 100306HCSR-S-V - 1903085WL and 1904015PL; 100308HCSR-S-V - 1904105UH, 1904155UH, 1903015PL, 1903015WL, 1903045WL, 1903085WL, 1903185WL, 1905135WL, and 1905175PL; 100310HC-S-V - 1903045VL, 1904155LL, 1905035LL, 1905065LL, and 1905155LL; 100310HCSR-S-V - 1904245UL, 1904265UL, 1903015WL, 1903085WL, and 1903185WL; 100410HC-S-V - 1904155LL, 1904175LL, 1905035LL, 1905065LL, and 1905135RL; and 100410HCSR-S-V - 1904105UL, 1903015WL, 1903085WL, and 1903185WL.