CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM
FDA device recall Z-0434-2026 · posted 2025-11-13 · Open, Classified
Recall details
- Recalling firm
- Cerenovus Inc
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- HCG
- Quantity affected
- 12004
- 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.
- Date initiated
- 2025-10-02
- Date posted
- 2025-11-13
- Location
- Miami, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems (K220040) | Medos International SARL | 2022-07-14 |