Miami, FL, United States
Cerenovus Inc recalls
1 recall recorded since 2018, most recently on 2 October 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 2 October 2025
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0434-2026
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.