FDAFDA · Food and drugs·Recall number Z-1401-2020
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.
Published March 4, 2020 · Recall initiated: November 22, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The devices may be missing the implant coil.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Microvention, Inc.
- Distributor
- 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
- Catalog/lot numbers: 180512CC-V - 1905205W3; 180820CC-V - 1903115L3; 181026CC-V - 1903115L3; 181434CC-V - 1903115L3, 1905155W3, and 1905205R3; and 182050CC-V - 1905205W3, 1903115L3, 1903115L3, 1903115L3, 1905155W3, and 1905205R3.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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