Z-1404-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- November 22, 2019
- Termination Date
- January 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units
Product Description
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.
Reason for Recall
The devices may be missing the implant coil.
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.
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.