Medtronic Recalls Pipeline Vantage 027, Updates IFU for Pipeline Vantage 021

March 18, 2025—The FDA announced that Medtronic initiated a device recall and correction for embolization devices. The FDA has identified this recall as the “most serious type.”

According to the FDA, on January 30, Medtronic Neurovascular sent all affected customers an Urgent Medical Device Recall letter.

Medtronic Neurovascular is (1) recalling the Pipeline Vantage 027 embolization device models from where they are used or sold and (2) updating instructions for use (IFU) for the Pipeline Vantage 021 embolization device. Both devices are used to treat cerebral aneurysms.

The FDA stated that these actions are being taken “due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall (incomplete wall apposition and/or braid deformation) during and after procedures using these devices.”

Incomplete wall apposition and braid deformation are known risks of these devices. The risks were higher in females, especially those patients aged < 45 years. The use of affected product may cause serious adverse health consequences, including thrombosis, stroke, or death, noted the FDA.

FDA advised that there have been 13 reported injuries and four reported deaths related to the 027-compatible Pipeline Vantage embolization device. There have been four reported injuries and no reported deaths related to the 021-compatible Pipeline Vantage embolization device.

Further actions for providers, specific revisions to the IFU, and other information are available online in the FDA recall notification here.