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The U.S. Food and Drug Administration (FDA) is aware that J&J MedTech and their subsidiary, CERENOVUS Inc., have issued a letter to affected customers recommending certain CEREPAK products be removed from where they are used or sold. J&J MedTech is removing CEREPAK Detachable Coil Systems due to a higher-than-expected failure to detach rate. The failure to detach could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
As of October 14, 2025, J&J MedTech has reported four serious injuries and one death associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact J&J Medtech (CERENOVUS Inc.) at OneMD-Field-Actions@its.jnj.com.
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