Microvention, Inc. recalls MicroVention Terumo HydroSoft 10, HydroCoil Embolic System,

Hazard / Issue

The devices may be missing the implant coil.

Issued by

FDA

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.

Lot/Code Info: Catalog/lot numbers: 100101H2HS-V - 1903135UR, 1903185UR, 1903225UR, and 1904035UR; 100102H2HS - V -1903135UR, 1903155UR, 1903155ZR, 1903185UR, 1903205UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR,1904155UR, 1904175UR, 1904175ZR, and 1904245UR; 100103H2HS-V - 1903015UR, 1903045UR, 1903065UR, 1903085UR, 1903135UR, 1903205UR 1904055UR, 1904085UR, 1904155UR, 1905085UR, 1905105UR, 1905135UR, and 1905155UR; 100104H2HS-V - 1903015UR, 1903135UR, 1903205UR, 1904085UR, 1904105UR, and 1904155UR; 100151H2HS-V - 1903085UR, 1903185UR, and 1904015UR; 100152H2HS-V - 1903135UR, 1903155UR, 1903205NR, 1903205UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065UR, 1905085UR, 1903045WR, 1903185WR, 1903205WR, 1904105WR, 1904175WR, 1904225WR, 1905065WR, and 1905175WR; 100153H2HS-V - 1903015UR, 1903065UR, 1903085UR, 1903185UR, 1904015UR, 1904015ZR, 1904105UR, 1904155UR, 1904245UR, 1904265UR, and 1904295UR; 100154H2HS-V - 1903135UR, 1903155UR, 1903205UR, 1903225UR, 1904015UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065NR, 1905065UR, 1905155NR, 1903185WR, 1903205WR, 1904105WR, 1904225WR, and 1905065WR; 100201H2HS-V - 1905105PR; 100202H2HS-V - 1903155UR, 1904105UR, 1903185WR, 1903205WR, 1904175WR, 1905065WR, 1905135WR, and 1905155WR; 100203H2HS-V - 1903015UR, 1904015ZR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1905025UR, 1905035NR, 1905035UR, 1905065UR, 1905085UR, 1905135NR, 1905155NR, 1903185WR, and 1905035WR; 100204H2HS-V - 1903015UR, 1903065UR, 1903085UR, 1904035UR, 1904155UR, 1904175UR, 1904175ZR, 1904225UR, 1904245UR, 1904245ZR, 1904265UR, 1904295UR, 1905025UR, 1905035NR, 1905035UR, 1905065UR, 1905085UR, 1905135NR, 1905155NR, 1904105WR, 1904175WR, 1905035WR, 1905065WR, 1905085WR, 1905135WR, and 1905155WR; 100206H2HS-V - 1903045UR, 1903065UR, 1903205UR, 1903225UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065NR, 1905065UR, 1905085UR, 1905105UR, 1905135UR, 1903185WR, 1904225WR, 1905065WR, 1905105PR, and 1905135WR; 100208H2HS-V - 1903015UR, 1903045UR, 1903085UR, 1903205UR, 1903225UR, 1904015UR 1904035UR, 1904175ZR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065UR, 1905085UR, 1905105UR, 1905135UR, and 1905085WR; 100254H2HS-V - 1904245NR, 1903185WR, and 1905065WR; 100256H2HS-V - 1905065WR; 100304H2HS-V - 1903065WR, 1903205WR, and 1904225WR; 100306H2HS-V - 1903065UR, 1903085UR, 1904155UR, 1904175UR, 1904225UR, 1905135NR, 1905035WR, 1905065WR, 1905105PR, 1905135WR, and 1905155WR; 100308H2HS-V - 1904015UR, 1904155UR, 1904175UR, 1904225UR, 1904265UR, 1904295UR, 1905025UR, 1905065NR, 1905085UR, 1905105UR, 1905135NR, 1905155NR, 1903065WR, 1903185WR, 1903205WR, 1905065WR, 1905105WR, 1905155WR, and 1905225WR; 100310H2HS-V - 1903135UR, 1903155UR, 1903185UR, 1903205UR, 1904015UR, 1904035UR, 1904055UR, 1904085UR, 1904155UR, 1904175UR, 1904175ZR, 1904225UR, 1904245UR, 1904295UR, 1905085WR, and 1905225WR; 100404H2HS-V - 1904175WR, 1904225WR, 1905035WR, 1905065WR, and 1905155WR; 100406H2HS-V - 1903205WR, 1904175WR, and 1905035WR; 100408H2HS-V - 1903085UR, 1903135UR, 1903155UR, 1903155ZR, 1903185UR, 1903225UR,1904015UR, 1904035UR, 1904055UR, 1904225UR, 1903155PR, 1903205WR, 1904105WR, 1904245WR, and 1905065WR; 100410H2HS-V - 1903115UR, 1903155UR, 1903205UR, 1904155UR, 1904175UR, 1904225UR, 1903045WR, and 1905085WR; 100506H2HS-V - 1905155WR; 100508H2HS-V - 1903205WR; 100510H2HS-V - 1903045WR, 1905085WR, and 1905225WR; 100515H2HS-V - 1903065WR, 1903225W6, 1904175WR, 1905085WR, and 1905225WR; 100520H2HS-V - 1904155WR, 1904175WR, 1905085WR, and 1905225WR; 100620H2HS-V - 1903045WR, 1904175WR, 1904225WR, 1905085WR; and MV-00208HHSA - 1904175YR, 1905065XR, and 1905085YR.