Medtronic’s Embolization Devices Get FDA Class I Recall After 4 Patient Deaths

The FDA issued a Class I recall of Medtronic’s Pipeline Vantage embolization devices with Shield Technology this week, specifically those compatible with 0.027-inch inner diameter microcatheters (Pipeline Vantage 027).

Class I recalls are the most serious classification, indicating that there is potential for serious injury or death.

The move follows reports of four patient deaths and 13 injuries associated with these devices.

​Doctors use embolization devices to treat brain aneurysms by diverting blood flow away from the aneurysm site.

The recall includes the removal of Pipeline Vantage 027 device models from all usage and sales locations, as well as updates to the usage instructions for Pipeline Vantage 021 device models.

Medtronic’s Pipeline Vantage embolization devices treat brain aneurysms, which are bulges in artery walls. Physicians insert the devices through a small catheter, and they consist of a braided tube that redirects blood flow away from the aneurysm. By reducing pressure on the bulging vessel, the device helps lower the risk associated with unruptured aneurysms.

The recall stems from incidents where the device’s braided tube failed to properly attach or remain attached to the blood vessel wall (incomplete wall apposition) during and after procedures, leading to severe health risks such as thrombosis, stroke or death. According to the FDA, incomplete wall apposition and braid deformation — often known as fish-mouthing, braid narrowing or braid collapse — pose risks with these devices.

Notably, these complications have been observed more frequently in females, especially those under 45 years of age. ​

Related: Tack Endovascular System Recall: Philips Responds to Arterial Repair Issues

Regulatory Responses to Medtronic’s Embolization Devices

According to a Health Canada notice issued in February, as of December 31, 2024, Medtronic received 416 complaints associated with approximately 18,200 Pipeline Vantage 027 units distributed globally.

The agency noted that the Vantage 027 devices “appear to exhibit a higher incidence of stent braid deformation compared to the Pipeline Shield.”

Stent braid deformations are generally observed between six to 12 months after follow-up. The risk is higher in women, especially those aged 45 and younger.

Medtronic and the FDA have advised discontinuing the use of all affected Pipeline Vantage 027 devices, instructing their immediate removal and quarantine.

Medtronic Neurovascular began recalling two products from its Pipeline Vantage range in January, the FDA said in the Class I recall notice.

In its Urgent Medical Device Recall letter, Medtronic advised to discontinue the use of all affected Pipeline Vantage 027 devices and instructed their immediate removal and quarantine.

Medtronic also provided updated instructions for the Pipeline Vantage 021 device.

According to the FDA, the updates improve device size selection and stent braid deployment, lowering the risk of complications and patient harm by reducing the incidence of incomplete wall apposition and/or braid deformation.

The FDA urges healthcare professionals and patients to report any adverse reactions or quality issues related to these devices to the MedWatch Safety Information and Adverse Event Reporting Program.

This isn’t the first time that Medtronic’s embolization devices have run into trouble. In 2021, the FDA issued a Class I recall of the company’s Pipeline Flex embolization devices for risk of delivery system fractures during placement, retrieval or movement.