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The 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. Affected devices:
Do not use affected product. Identify and segregate all affected devices that are in inventory or consignment at your facility.
On October 2, 2025, J&J MedTech sent all affected customers a letter recommending the following actions:
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.
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.
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.
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch.
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