Microvention, Inc. recalls Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coi

Hazard / Issue

The devices may be missing the implant coil.

Issued by

FDA

Distribution: The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.

Lot/Code Info: Catalog/lot numbers: 45-751019 - 1903045J2, 1903065J2, 1903085J2, 1904155J2, 1904175J2, 1904265J2, 1904295J2, 1905035J2, 1905085J2, 1905105K2, and 1905135J2; 45-751324 - 1903045J2, 1903155J2, 1903205J2, 1903225J2, 1904155J2, 1904225J2, 1904265J2, 1904295J2, 1905065J2, and 1905085J2; 45-751632 - 1903045J2, 1903065J2, 1903205J2, 1903225J2, 1904175J2, 1904265J2, 1904295J2, 1905035J2, 1905065J2, and 1905085J2; 45-752039 - 1903045J2, 1903205J2, 1904265J2, 1905035J2, and 1905065J2; 45-750407 - 1903045J2, 1903065J2, 1903085J2, 1903115J2, 1903155J2, 1904175J2, 1904175K2, 1904225J2, 1904245J2, 1904265J2, and1904295J2 45-750511 - 1903045J2, 1903065J2, 1903085J2, 1903155J2, 1904175J2, 1904175K2, 1904225J2, 1904245J2, 1904265J2, 1904295J2; 45-750617 - 1903045J2, 1903065J2, 1903085J2, 1903155J2, 1904055J2, 1905035J2, 1905065J2, and 1905085J2; 45-750609 - 1903045J2, 1903065J2, 1903085J2, and 1904035J2; 45-750812 - 1903045J2, 1903085J2, 1905035J2, 1905065J2, and 1905085J2; 45-750824 - 1903045J2, 1903065J2, 1903155J2 ,1904055J2, 1905035J2, 1905065J2, and 1905085J2; MV-AX50407CD - 1904015J9, 1904035J9, and 1904085J9; MV-AX50511CD - 1904015J9, 1904035J9, and 1904055J9; MV-AX50617CD - 1904015J9 and 1904035J9; MV-AX50824CD - 1904015J9 and 1904035J9; and MV-AX51019CD - 1905105J9.