Cerepak (vascular implants)

2026: Finding a marriage that causes a stroke

On February 5, 2026, the U.S. Food and Drug Administration (FDA) announced the recall of Cerepak vascular products manufactured by Cerenovus's division of Johnson & Johnson MedTech. The use of defective devices can cause significant harm to the health of patients or even provoke a fatal outcome.

Cerepak's spiral design solutions are designed to embolize intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolization of peripheral vessels. The devices being recalled have problems detaching. The use of defective products can lead to hemorrhagic and ischemic stroke, delays in the procedure or the need for additional surgery.

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Фото: Johnson & Johnson

As of October 14, 2025, Johnson & Johnson MedTech reported four cases of serious harm to the health of patients and one fatal incident in connection with the application of Cerepak solutions. Medical institutions are urged to withdraw defective products from circulation. Sales of affected products have also been discontinued. The following devices are subject to recall:

• Cerepak Uniform Detachable Coil System;
• Cerepak Uniform XL Detachable Coil System;
• CerepakUniform 3D Detachable Coil System;
• CerepakHeliform Soft Detachable Coil System;
• CerepakHeliform XtraSoft Detachable Coil System;
• CerepakHeliform XL Detachable Coil System;
• CerepakHeliform XtraSoft XL Detachable Coil System;
• CerepakFreeform Detachable Coil System;
• CerepakFreeform Mini Detachable Coil System;
• CerepakFreeform XtraSoft Detachable Coil System.^[1]

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