Z-1398-2020 Class II Terminated
FDA device recall Z-1398-2020 was initiated by Microvention, Inc. on November 22, 2019 and is designated Class II. Reason for recall: The devices may be missing the implant coil. The recall status is terminated (terminated January 26, 2022). Affected quantity: 3,442 units.
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
- 3,442 units
Product Description
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V, 100825CSSR-V, 100837CSSR-V, 100933CSSR-V, and 101036CSSR-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: 100202CSSR-V - 1903155ZC, 1903185UC, 1903225UC, 1904085UC, 1904225NC, 1905155ZC, 1905205UC, 1905205ZC, 1905225UC, 1903015WC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1905065WC, 1905085WC, 1905105WC, 1905175WC, 1905205WC, and 1905225WC; 100254CSSR-V - 1904105UC, 1904155UC, 1904175UC, 1904225ZC, 1904245UC, 1905025UC, 1905035UC, 1905065UC, 1905105UC, 1905135UC, 1905155UC, 1905175UC, 1905205UC, 1903015WC, 1904015WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, 1905175WC, and 1905225WC; 100306CSSR-V - 1903045UC, 1903065UC, 1903085UC, 1903115UC, 1903135UC, 1903155ZC, 1903185UC, 1903205UC, 1903225UC, 1904035RC, 1904105UC, 1904155UC, 1904175UC, 1904225UC, 1904245UC, 1904265UC, 1904295UC, 1905035UC, 1905065UC, 1905085UC, 1905105UC, 1905105ZC, 1905135UC, 1905155UC, 1905175UC, 1905205UC, 1905205ZC, 1905225UC, 1903015WC, 1903045WC, 1903065WC, 1903205WC, 1904015WC, 1904055WC, 1904085WC, 1904225PC, 1904225WC, 1904245WC, 1904245WH, 1904245WT, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905105WC, 1905155PC, and 1905205WC; 100408CSSR-V - 1903065UC, 1904015UC, 1904035RC, 1904035UC, 1904055UC, 1904055ZC, 1904085UC, 1903015WC, 1904015WC, 1904035WC, 1904155WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905155WC, and 1905175WC; 100412CSSR-V - 1903185UC, 1903205UC, 1903225UC, 1905085UC, 1905105ZC, 1905135UC, 1905225UC, 1903045WC, 1903085WC, 1903205WC, 1903225WC, 1904175PC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905155WC, 1905175WC, 1905205WC, and 1905225WC; 100515CSSR-V - 1903185UC, 1903205UC, 1904035RC, 1904155UC, 1904175UC, 1904225UC, 1904225ZC, 1904245UC, 1904265UC, 1905025UC, 1905035UC, 1905065UC, 1905085UC, 1905105UC, 1905135UC, 1905155UC, 1905205UC, 1905225UC, 1905225ZC, 1903015WC, 1903065WC, 1903085WC, 1903185WC, 1903205WC, 1904015WC, 1904035WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905225WC; 100522CSSR-V - 1904155UC, 1904175UC, 1904225UC, 1904245UC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904055WC, 1904175WC, 1904245WC, 1904265WC, 1904295WC, 1905035WC, 1905065WC, 1905155WC, 1905175WC, and 1905205WC; 100618CSSR-V - 1903205LC, 1905155LC, 1905205LC, 1905205VC, 1903045WC, 1903085WC, 1903185WC, 1904175WC, 1904225WC, 1904245WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905225WC; 100626CSSR-V - 1903015LC, 1903045WC, 1903065WC, 1903205WC, 1904015WC, 1904295WC, 1905065WC, 1905085WC, and 1905205WC; 100722CSSR-V - 1903015WC, 1903065WC, 1903185WC, 1904015WC, 1904175WC, 1904265WC, 1904295WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905175WC; 100731CSSR-V - 1903015WC, 1903045WC, 1903065WC, 1905085WC, 1905105WC, 1905155WC, and 1905205PC; 100825CSSR-V - 1903015WC, 1903045WC, 1904015WC, 1904105WC, 1904175PC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905085WC, 1905155PC, and 1905175WC; 100837CSSR-V - 1903015WC, 1903065WC, 1903085WC, 1904015WC, 1905105WC, 1905135WC, and 1905205WC; 100933CSSR-V - 1905135RC, 1903015WC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904265WC, 1905105WC, 1905175WC, and 1905225WC; and 101036CSSR-V - 1903015WC, 1903065WC, 1903085WC, 1903115WC, 1903205WC, 1905155WC, and 1905225WC.