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Recall Observatory FDA recall evidence

Device product

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-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.

Z-1404-2020

November 22, 2019

Class II

Product summary

Firm
Microvention, Inc.
Event
Event 84727
Status
Terminated
Classification
Class II
Quantity
85 units
Official record key
device-enforcement:Z-1404-2020

Official wording

Reason: The devices may be missing the implant coil.

Code information: Catalog/lot numbers: 100203CMSR-V - 1903085WP; 100408CMSR-V - 1903085WP and 1904015PP; 100412CMSR-V - 1904225RP, 1905205QP, and 1904035PP; 100510CMSR-V - 1905205QP and 1904085WP; 100516CMSR-V - 1903135WP and 1905155WP; 100612CMSR-V - 1903225WP; 100618CMSR-V - 1903135QP and 1904085WP; and 100721CMSR-V - 1903085RP.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The devices may be missing the implant coil.