Medtronic Pipeline Recall Issued After Embolization Device Linked to Injuries, Deaths

Manufacturer has issued recall and updated instructions for two separate models of Medtronic Pipeline Vantage devices.

Federal officials are warning that certain Medtronic Neurovascular devices used to treat brain aneurysms may fail to properly attach to blood vessel walls, potentially leading to serious injuries or death.

The U.S. Food and Drug Administration (FDA) announced the Medtronic Pipeline Vantage recall on March 18, advising healthcare providers to remove certain device models from use or sale and to review the updated instructions for other models.

Pipeline Vantage Embolization devices are braided stents made of cobalt-chromium and platinum, which are inserted into blood vessels through a small catheter to help treat aneurysms. Once there, the tube is used to block off blood flow to the brain region where the aneurysm is occurring.

Incomplete attachment to blood vessel walls has been a known risk factor for these devices. However, the manufacturer has now received reports of higher incidences of the braided tube failing to properly attach or stay attached to the vessels during and after procedures, which can lead to thrombosis, stroke or death.

Medtronic Neurovascular first issued an Urgent Medical Device Recall on January 30, 2025, following reports of 13 injuries and four deaths associated with the Medtronic Embolization Device with Shield Technology, 027 model. Additionally, there were four reported injuries linked to the Medtronic Pipeline Vantage Embolization Device with Shield Technology, 021 model.

The company pointed out that the risk of injury appears more likely for women under the age of 45.

As a result, the FDA has classified this action as a Class I recall, the most serious type, indicating that continued use of the product could result in serious injury or death.

The recall involves the removal of Pipeline Vantage Embolization with Shield Technology 027 compatible devices, as well as updated instructions for the 021 compatible devices.

A full list of the affected products’ Unique Device Identifiers and catalog numbers can be found in the FDA recall notice.

The correction letter instructs providers to stop using and return all unused Pipeline Vantage 027 devices, and to consult the updated instructions before deploying Pipeline Vantage 021 devices. Providers should quarantine and return unused 027 devices to Medtronic, where representatives will assist with securing suitable replacements. 

The revised guidelines for the 021 model enhance device size selection and stent braid deployment, aiming to minimize risks like incomplete wall attachment and braid deformation, and provide detailed advice on choosing the right device dimensions, deployment techniques, and handling potential deployment issues.

Medtronic is requesting that customers complete and return the customer confirmation form to neuro.quality@medtronic.com.

Patients treated with Pipeline Vantage 027 and 021 devices should consult their physician to assess the need for follow-up imaging or adjustments to medical management based on their overall health.

For more information, customers can contact their local Medtronic representative or Medtronic Quality Assurance at rs.nvquality@medtronic.com or 1-800-633-8766.

Medtronic Device Quality Issues

Earlier versions of similar Medtronic products have also been the subject of multiple recalls.

In September 2021, nearly 9,000 Medtronic Pipeline Flex Embolization devices for brain aneurysms were recalled, following reports of serious injuries and at least two deaths that may have been caused by broken pieces of the device entering patients’ brains.

An earlier recall of a number of Medtronic Neurovascular devices, including Pipeline embolization devices, Alligator retrieval devices, X-Celerator hydrophilic guidewires, as well as Ultraflow and Marathon Flow Directed Micro Catheters, was announced in October 2016, due to fears that the devices’ coatings may flake off and enter the bloodstream, potentially increasing the risk of blood clots and other injuries.