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Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF num
Recalled March 4, 2020 · FDA recall Z-1400-2020 · Microvention
Hazard
The devices may be missing the implant coil. · FDA Class II
Units
409 units
Sold at
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.
Description
The devices may be missing the implant coil.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-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.
Manufacturer(s)
Microvention, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →