Recall Z-0434-2026 ยท HCG Device, Neurovascular Embolization
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 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,
| Date | Nov 13, 2025 (initiated Oct 2, 2025) |
| Status | Open, Classified |
| Reason | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. |
| Root cause | 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 facil |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Medos International SARL, Jul 14, 2022 |