Z-0434-2026 Class I Ongoing

CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X 11.9 CM/FCX100611, UNIFORM 6MM X 26 CM/FCX100626, UNIFORM 7MM X 13.9 CM/FCX100713, UNIFORM 7MM X 30 CM/FCX100730, UNIFORM 8MM X 16.1 CM/FCX100816, UNIFORM 8MM X 29 CM/FCX100829, UNIFORM 3D 2MM X 2.5 CM/FCX140225, UNIFORM 3D 3MM X 3 CM/FCX140303, UNIFORM 3D 3MM X 4 CM/FCX140304, UNIFORM 3D 3MM X 6 CM/FCX140306, UNIFORM 3D 4MM X 6 CM/FCX140406, UNIFORM 3D 4MM X 8 CM/FCX140408, UNIFORM 3D 4MM X 4.5 CM/FCX140445, UNIFORM 3D 5MM X 7 CM/FCX140507, UNIFORM 3D 5MM X 12 CM/FCX140512, UNIFORM 3D 6MM X 9 CM/FCX140609, UNIFORM 3D 6MM X 15 CM/FCX140615, UNIFORM 3D 7MM X 11 CM/FCX140711, UNIFORM 3D 7MM X 17 CM/FCX140717, UNIFORM 3D 8MM X 12 CM/FCX140812, UNIFORM 3D 8MM X 20 CM/FCX140820, UNIFORM 3D 9MM X 14 CM/FCX140914, UNIFORM 3D 9MM X 22 CM/FCX140922, UNIFORM 3D 10MM X 16 CM/FCX141016, UNIFORM 3D 10MM X 25 CM/FCX141025, UNIFORM 3D 11MM X 18 CM/FCX141118, UNIFORM 3D 11MM X 27 CM/FCX141127, UNIFORM 3D 12MM X 19 CM/FCX141219, UNIFORM 3D 12MM X 30 CM/FCX141230, UNIFORM XL 5MM X 10 CM/FCX180510, UNIFORM XL 6MM X 12.2 CM/FCX180612, UNIFORM XL 7MM X 14.3 CM/FCX180714, UNIFORM XL 8MM X 13.6 CM/FCX180813, UNIFORM XL 8MM X 30 CM/FCX180830, UNIFORM XL 9MM X 15.3 CM/FCX180915, UNIFORM XL 9MM X 33 CM/FCX180933, UNIFORM XL 10MM X 17.1 CM/FCX181017, UNIFORM XL 10MM X 34 CM/FCX181034, UNIFORM XL 11MM X 18.9 CM/FCX181118, UNIFORM XL 11MM X 37 CM/FCX181137, UNIFORM XL 12MM X 20.7 CM/FCX181220, UNIFORM XL 12MM X 40 CM/FCX181240, UNIFORM XL 13MM X 43 CM/FCX181343, UNIFORM XL 14MM X 47 CM/FCX181447, UNIFORM XL 15MM X 50 CM/FCX181550, UNIFORM XL 16MM X 47 CM/FCX181647, UNIFORM XL 17MM X 50 CM/FCX181750, UNIFORM XL 18MM X 46 CM/FCX181846, UNIFORM XL 19MM X 50 CM/FCX181950, UNIFORM XL 20MM X 50 CM/FCX182050, FREEFORM MINI 1MM X 1CM/MCR091010, FREEFORM MINI 1MM X 1.5CM/MCR091015, FREEFORM MINI 1MM X 2CM/MCR091020, FREEFORM MINI 1MM X 2.5CM/MCR091025, FREEFORM MINI 1MM X 3CM/MCR091030, FREEFORM MINI 1MM X 4CM/MCR091040, FREEFORM MINI 1.5MM X 2CM/MCR091520, FREEFORM MINI 1.5MM X 2.5CM/MCR091525, FREEFORM MINI 1.5MM X 3CM/MCR091530, FREEFORM MINI 1.5MM X 4CM/MCR091540, FREEFORM MINI 2MM X 2CM/MCR092020, FREEFORM MINI 2MM X 3CM/MCR092030, FREEFORM MINI 2MM X 4CM/MCR092040, FREEFORM MINI 2MM X 6CM/MCR092060, FREEFORM MINI 2.5MM X 3.5CM/MCR092535, FREEFORM MINI 2.5MM X 4.5CM/MCR092545, FREEFORM MINI 2.5MM X 5.5CM/MCR092555, FREEFORM MINI 3MM X 4CM/MCR093040, FREEFORM MINI 3MM X 6CM/MCR093060, FREEFORM MINI 3MM X 8CM/MCR093080, FREEFORM 2MM X 2 CM/SCR120202, FREEFORM 3MM X 6 CM/SCR120306, FREEFORM 3MM X 8 CM/SCR120308, FREEFORM 4MM X 7 CM/SCR120407, FREEFORM 4MM X 10 CM/SCR120410, FREEFORM 4MM X 12 CM/SCR120412, FREEFORM 5MM X 10 CM/SCR120510, FREEFORM 5MM X 15 CM/SCR120515, FREEFORM 6MM X 10 CM/SCR120610, FREEFORM 6MM X 15 CM/SCR120615, FREEFORM 6MM X 20 CM/SCR120620, FREEFORM 7MM X 15 CM/SCR120715, FREEFORM 7MM X 21 CM/SCR120721, FREEFORM 8MM X 15 CM/SCR120815, FREEFORM 8MM X 24 CM/SCR120824, FREEFORM 9MM X 25 CM/SCR120925, FREEFORM 10MM X 30 CM/SCR121030, FREEFORM 12MM X 30 CM/SCR121230, FREEFORM 2.5MM X 5 CM/SCR122505, FREEFORM 2.5MM X 3.5 CM/SCR122535, FREEFORM 3.5MM X 9 CM/SCR123509, FREEFORM 3.5MM X 7.5 CM/SCR123575, HELIFORM SOFT 1.5MM X 4 CM/SHD100154, HELIFORM SOFT 2MM X 8 CM/SHD100208, HELIFORM SOFT 2.5MM X 10 CM/SHD100250, HELIFORM SOFT 2.5MM X 8 CM/SHD100258, HELIFORM SOFT 3MM X 8 CM/SHD100308, HELIFORM SOFT 3MM X 10 CM/SHD100310, HELIFORM SOFT 4MM X 8 CM/SHD100408, HELIFORM SOFT 4MM X 10 CM/ SHD100410, HELIFORM SOFT 5MM X 10 CM/ SHD100510, HELIFORM SOFT 5MM X 15 CM/ SHD100515, HELIFORM SOFT 6MM X 12 CM/ SHD100612, HELIFORM SOFT 6MM X 16 CM/ SHD100616, HELIFORM SOFT 7MM X 16 CM/ SHD100716, HELIFORM SOFT 7MM X 20 CM/ SHD100720, HELIFORM SOFT 8MM

Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.

All devices/lots manufactured prior to and including August 2025 are affected. REF/UDI-DI: FCX100202/10886704083986, FCX100253/10886704083979, FCX100305/10886704083962, FCX100356/10886704083993, FCX100407/10886704084013, FCX100412/10886704084006, FCX100509/10886704084037, FCX100517/10886704084020, FCX100611/10886704084044, FCX100626/10886704084051, FCX100713/10886704084068, FCX100730/10886704084075, FCX100816/10886704084082, FCX100829/10886704084099, FCX140225/10886704084167, FCX140303/10886704084174, FCX140304/10886704084181, FCX140306/10886704084198, FCX140406/10886704084211, FCX140408/10886704084228, FCX140445/10886704084204, FCX140507/10886704084242, FCX140512/10886704084235, FCX140609/10886704084266, FCX140615/10886704084259, FCX140711/10886704084273, FCX140717/10886704084280, FCX140812/10886704084297, FCX140820/10886704084303, FCX140914/10886704084310, FCX140922/10886704084327, FCX141016/10886704084105, FCX141025/10886704084112, FCX141118/10886704084129, FCX141127/10886704084136, FCX141219/10886704084143, FCX141230/10886704084150, FCX180510/10886704084464, FCX180612/10886704084471, FCX180714/10886704084488, FCX180813/10886704084495, FCX180830/10886704084501, FCX180915/10886704084518, FCX180933/10886704084525, FCX181017/10886704084334, FCX181034/10886704084341, FCX181118/10886704084358, FCX181137/10886704084365, FCX181220/10886704084372, FCX181240/10886704084389, FCX181343/10886704084396, FCX181447/10886704084402, FCX181550/10886704084419, FCX181647/10886704084426, FCX181750/10886704084433, FCX181846/10886704084440, FCX181950/10886704084457, FCX182050/10886704082880, MCR091010/10886704082897, MCR091015/10886704082903, MCR091020/10886704082910, MCR091025/10886704082927, MCR091030/10886704082934, MCR091040/10886704082941, MCR091520/10886704082958, MCR091525/10886704082965, MCR091530/10886704082972, MCR091540/10886704082989, MCR092020/10886704084778, MCR092030/10886704082996, MCR092040/10886704083009, MCR092060/10886704083016, MCR092535/10886704083023, MCR092545/10886704083030, MCR092555/10886704083047, MCR093040/10886704083054, MCR093060/10886704083061, MCR093080/10886704083078, SCR120202/10886704083085, SCR120306/10886704083092, SCR120308/10886704083108, SCR120407/10886704083115, SCR120410/10886704083122, SCR120412/10886704083139, SCR120510/10886704083146, SCR120515/10886704083153, SCR120610/10886704083160, SCR120615/10886704083177, SCR120620/10886704083184, SCR120715/10886704083191, SCR120721/10886704083207, SCR120815/10886704083214, SCR120824/10886704083221, SCR120925/10886704083238, SCR121030/10886704083245, SCR121230/10886704083252, SCR122505/10886704083269, SCR122535/10886704083276, SCR123509/10886704083283, SCR123575/10886704083290, SHD100154/10886704083306, SHD100208/10886704083313, SHD100250/10886704083320, SHD100258/10886704083337, SHD100308/10886704083344, SHD100310/10886704083351, SHD100408/10886704083368, SHD100410/10886704083375, SHD100510/10886704083382, SHD100515/10886704083399, SHD100612/10886704083405, SHD100616/10886704083412, SHD100716/10886704083429, SHD100720/10886704083436, SHD100820/10886704083443, SHD100925/10886704083450, SHD180312/10886704083467, SHD180415/10886704083474, SHD180520/10886704083481, SHD180625/10886704083498, SHD180733/10886704083504, SHD180835/10886704083511, SHD180935/10886704083528, SHD181040/10886704083535, SHD181242/10886704083542, SHD181445/10886704083559, SHD181650/10886704083566, SHD181855/10886704083573, SHD182060/10886704083580, SHD182260/10886704083597, SHD182460/10886704083603, XCR120201/10886704083610, XCR120202/10886704083627, XCR120304/10886704083634, XCR120306/10886704083641, XCR120308/10886704083658, XCR120406/10886704083665, XCR120408/10886704083672, XCR120410/10886704083689, XCR120510/10886704083696, XCR120515/10886704083702, XCR120610/10886704083719, XCR120620/10886704083726, XCR122505/10886704083733, XCR122525/10886704083740, XCR122535/10886704083757, XCR123505/10886704083764, XCR123509/10886704083771, XCR123575/10886704083788, XHD100151/10886704083795, XHD100152/10886704083801, XHD100153/10886704083818, XHD100201/10886704083825, XHD100202/10886704083832, XHD100203/10886704083849, XHD100204/10886704083856, XHD100206/10886704083863, XHD100254/10886704083870, XHD100256/10886704083887, XHD100304/10886704083894, XHD100306/10886704083900, XHD100406/10886704083917, XHD100408/10886704083924, XHE120204/10886704083931, XHE120206/10886704083948, XHE120208/10886704083955, MDH1/10886704084600