MicroVention Terumo Microplex 10 recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog/lot numbers: 100102HS3D-V - 1903045WT, 1903065WT, 1903205WT, 1904015WT, 1904035WT, 1904245WT, 1904255WT, 1904265WT, 1904295WT, 1905025WT, 1905065WT, 1905085WT, 1905155WT, 1905175WT, and 1905205WT; 100103HS3D-V - 1903115TT, 1903015WT, 1903085WT, 1903135WT, 1904015WT, 1904035WT, 1904055WT, 1904105WT, 1904265WT, 1904295WT, 1905035WT, 1905105PT, 1905135WT, 1905155WT, and 1905225WT; 100152HS3D-V - 1903065NT, 1903045WT, 1903085WT, 1903205WT, 1903225WT, 1904015WT, 1904105WT, 1904175WT, 1904295WT, 1905025WT, 1905105WT, 1905135WT, 1905155WT, and 1905175WT; 100153HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903155WT, 1904015WT, 1904035WT, 1904265WT, 1904295WT, 1905135WT, and 1905205WT; 100154HS3D-V - 1903045WT, 1903085WT, 1903135WT, 1903185WT, 1903225WT, 1904015WT, 1904035WT, 1904085WT, 1904105WT, 1904155WT, 1904175WT, 1904225WT, 1905025WT, 1905135WT, 1905155PT, 1905155WT, 1905175WT, and 1905205WT; 100202HS3D-V - 1903015WT, 1903065WT, 1903185WT, 1903205WT, 1905105WT, and 1905205WT; 100203HS3D-V - 1904015WT, 1904035WT, 1904265WT, 1904295WT, 1905065WT, 1905085WT, 1905155WT, and 1905225PT; 100204HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903085WT, 1904035WT, 1904055WT, 1904085WT, 1904245WT, 1904255WT, 1904295WT, 1905035WT, 1905065WT, and 1905085WT; 100206HS3D-V - 1904175WT, 1904225WT, 1904245WT, 1905105WT, 1905155PT, and 1905155WT; 100208HS3D-V - 1903085WT, 1903155WT, 1904035WT, 1905155PT, and 1905155WT; 100254HS3D-V - 1903015WT, 1903065WT, 1904015WT, 1904035WT, 1904055WT, 1904155WT, 1904225WT, 1904245WT, 1905035PT, 1905065WT; 100256HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903085WT, 1904015WC, 1904015WT, 1904035WT, 1904175WT, 1904245WT, 1904255WT, 1904265WT, 1904295WT, 1905035WH, 1905035WT, 1905155PT, and 1905225WT; 100304HS3D-V - 1903065WT, 1903115WT, 1903155WT, 1903205WT, 1904015WT, 1904055WT, 1904255WT, 1905105WT, 1905175WT, and 1905205WT; 100306HS3D-V - 1903085NT, 1903015WT, 1903085WT, 1903115WT, 1903135WT, 1903155WT, 1904015WT, 1904035WT, 1904055WT, 1904085WT, 1904225PT, 1904225WT, 1904245WT, 1904255WT, 1904265WT, 1905135WT, 1905175WT, and 1905205WT; 100310HS3D-V - 1903085WT and 1904035WT; 100355HS3D-V - 1903045WT, 1903085WT, 1904015WT, 1904225PT, 1904225WT, and 1905175WT; 100358HS3D-V - 1903065WT, 1904255WT, 1904265WT, 1904295WT, 1905035WT, 1905065WT, 1905085WT, 1905155WT, and 1905175WT; 100406HS3D-V - 1903015WT, 1903115WT, 1903205WT, 1904015WT, and 1905205WT; 100408HS3D-V - 1905205NT,1903085WT, 1903205WT, 1904015WT, 1904035WT, 1904055WT, 1904175WT, 1904225PT, 1904225WT, 1904255WT, 1904265WT, 1904295WT, 1905025WT, 1905105WT, 1905155WT, and 1905175WT; 100412HS3D-V - 1903135WT, 1904035WT, 1904175WT, and 1905105WT; 100415HS3D-V - 1903135WT, 1904035WT, 1905105WT, and 1905155WT; 100510HS3D-V - 1903065WT, 1904015WT, 1904035WT, 1904245WT, 1905105WT, and 1905155WT; 100515HS3D-V - 1903085NT, 1903015WT, 1903045WT, 1903085WT, 1903185WT, 1903205WT, 1904015WT, 1904035WT, 1904175WT, 1904265WT, 1904295WT, 1905025WT, 1905035WT, 1905085WT, 1905175WT; MV-00102HTDA - 1903015YT, 1903045YT, 1903155XT, 1904105YT, and 1904155XT; MV-00103HTDA - 1903045YT, 1903185YT, 1905065YT, and 1905085YT; MV-00204HTDA - 1904085YT and 1905065YT; MV-00304HTDA - 1905085YT; MV-00306HTDA - 1903015YT, 1903155XT, and 1903155YT; MV-00406HTDA - 1903015YT, 1904055YT, 1905065YT, and 1905085YT; MV-00408HTDA - 1903155YT, 1904015XT, 1904085YT, 1905035XT, 1905065YT, and 1905085YT; MV-00510HTDA - 1904085YT and 1905085YT; MV-01502HTDA - 1903015YT, 1904085YT, 1904105YT, 1905085YT, and 1905105YT; MV-01503HTDA - 1904055YT, 1904085YT, 1905085YT, 1905105XT, and 1905135YT; MV-01504HTDA - 1904085YT, 1904105YT, 1905085YT, 1905105XT, 1905105YT, 1905135YT, and 1905155YT; MV-02504HTDA - 1903155YT, 1904055YT, and 1905085YT; MV-02506HTDA - 1903155YT, 1905085YT, and 1905105YT; and MV-03505HTDA - 1903015YT, 1903155YT, 1904085YT, 1905085YT, and 1905105YT; and MV-03508HTDA - 1904055YT, 1904085YT, 1905085YT, and 1905105XT.

Product

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V…

Recalling firm

Microvention, Inc.

Quantity

1,725 units

Distribution

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.

Recall date

March 4, 2020

Classification

Class II

Status

Terminated

Agency

FDA (device)