CLASS I ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report
Cerepak Detachable Coil System - Name recalled by Cerenovus
Cerenovus is recalling Cerepak Detachable Coil System - Name, distributed nationwide in the US. The recall was initiated on 2 Oct 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0434-2026
- FDA event ID
- 97814
- Recalling firm
- Cerenovus, Miami, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 2 Oct 2025
- FDA classified
- 13 Nov 2025
- Reported
- 19 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 Oct 2025 | Recall initiated by company | |
| 13 Nov 2025 | Classified by FDA | +42 days |
| 19 Nov 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisKentuckyLouisianaMassachusettsMarylandMaineMichiganMissouriNorth CarolinaNew Hampshire
Questions about this recall
Why was it recalled?
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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