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Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF num
Recalled March 4, 2020 · FDA recall Z-1401-2020 · Microvention
Hazard
The devices may be missing the implant coil. · FDA Class II
Units
19 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 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-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 →