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, the company has reported four serious injuries and one death associated with this issue.
The FDA said that J&J MedTech and its subsidiary, CERENOVUS, have issued a letter to affected customers recommending certain CEREPAK products be removed from where they are used or sold.
The CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, and Freeform Mini Detachable Coil Systems are indicated for embolization of intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature. The CEREPAK Freeform XtraSoft Detachable Coil System is indicated for embolization of intracranial aneurysms.
