Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.
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
Why it was 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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
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.
Recall record
- Recalling firm
- Cerenovus Inc
- Product type
- Devices
- Recall number
- Z-0434-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Miami, FL
- Recall initiated
- 2025-10-02
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0434-2026 · Source: openFDA enforcement.