| | Class 1 Device Recall CEREPAK Detachable Coil System |  |
| Date Initiated by Firm | October 02, 2025 |
|---|
| Date Posted | November 13, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0434-2026 |
|---|
| Recall Event ID |
97814 |
| 510(K)Number | K220040 |
|---|
| Product Classification |
Device, neurovascular embolization - Product Code HCG
|
| Product | 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 |
|---|
| 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
|
Recalling Firm/
Manufacturer |
Cerenovus Inc
6303 Blue Lagoon Dr Ste 315
Miami FL 33126-6068
|
| For Additional Information Contact | Samuel Shimp
305-265-6811 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | On 10/2/2025, Johnson & Johnson Med Tech mailed "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" notices dated 10/1/2025 to customers who were asked to do the following:
1. Immediately stop using the affected devices.
2. Identify and segregate all affected devices that are in inventory / consignment at your facility.
3. Firm sales representative will coordinate the removal of the product from your facility and will coordinate the credit, as applicable, for any customer-owned inventory.
4. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed.
5. If any product subject to this recall has been forwarded to another facility, contact that facility, provide a copy of this letter and notify J&J sales representative.
6. If the product has been successfully implanted, there is no additional action needed.
7. Complete and return the attached Business Reply Form in Attachment 2 to:
OneMD-Field-Actions@its.jnj.com. Please return the BRF even if you do not have product subject to this recall.
8. Keep this notice visibly posted for awareness until all product subject to this recall have been returned. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records.
If you have additional questions regarding this medical device recall (removal), please contact firm at OneMD-Field-Actions@its.jnj.com. |
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| Quantity in Commerce | 12004 |
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| 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.
|
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HCG
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