Medtronic recalls brain aneurysm device after reported deaths

IRELAND – Medtronic has recalled certain Pipeline Vantage embolization devices used to treat brain aneurysms after reports of serious safety issues, including multiple deaths.

The U.S. Food and Drug Administration (FDA) has classified the recall as Class I, the most serious type, due to the risk of severe injury or death.

The Pipeline Vantage embolization devices are designed to treat aneurysms by placing a small, flexible, braided tube inside blood vessels to block blood flow to the bulging area.

However, Medtronic discovered that some devices failed to properly attach to the blood vessel wall or became deformed during and after procedures.

This problem, known as incomplete wall apposition or braid deformation (fish-mouthing), increases the risk of complications such as stroke, blood clots (thrombosis), and death.

The recall affects Pipeline Vantage 027 models, which Medtronic is removing from use and sale.

The company is also updating instructions for the Pipeline Vantage 021 model to help doctors select the right device size and ensure proper deployment.

According to FDA data, Medtronic reported 13 injuries and four deaths linked to the 027 model.

The 021 model has had four reported injuries but no deaths. The risks appear to be higher in female patients under 45 years old.

On January 30, 2025, Medtronic issued an urgent medical device recall letter, advising customers to stop using the 027 devices and return any unused units.

The company instructed physicians to read the updated guidelines before using the 021 devices.

For patients already treated with the affected devices, doctors should assess whether follow-up imaging or changes in medical management are needed.

They must also balance the risks of dual antiplatelet therapy against the possibility of braid deformation.

“Patient safety remains our top priority, and we are committed to providing healthcare professionals with updated information to ensure the best possible outcomes,” Medtronic stated.