Cerenovus Inc: 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 4M

Hazard

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

Details from the source

Reason for recall: Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. Distribution: US Nationwide distribution: CO, GA, MD, UT, OK, WI, MA, TN, SC, TX, CA, WV, LA, IL, NY, IA, AZ, AL, CT, WA, OH, ME, DC, FL, SD, KY, NJ, DE, NC, PA, MI, MO, VA, NH, NV and OR. Quantity: 12004 Lot/code info: 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, FCX18

UPC codes

10886704083986, 10886704083979, 10886704083962, 10886704083993, 10886704084013, 10886704084006, 10886704084037, 10886704084020, 10886704084044, 10886704084051, 10886704084068, 10886704084075, 10886704084082, 10886704084099, 10886704084167, 10886704084174, 10886704084181, 10886704084198, 10886704084211, 10886704084228, 10886704084204, 10886704084242, 10886704084235, 10886704084266, 10886704084259, 10886704084273, 10886704084280, 10886704084297, 10886704084303, 10886704084310, 10886704084327, 10886704084105, 10886704084112, 10886704084129, 10886704084136, 10886704084143, 10886704084150, 10886704084464, 10886704084471, 10886704084488

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.