FDA issues Medtronic embolization device recall and correction notice

In a notice posted to the agency’s website, the FDA noted that on January 30, 2025, Medtronic (MDT) Neurovascular sent all affected customers an Urgent Medical Device Recall letter warning user to not use any affected Pipeline Vantage 027 devices. “Medtronic Neurovascular is recalling 027 Compatible Pipeline Vantage Embolization Devices and updating use instructions for 021 Compatible Pipeline Vantage Embolization Devices 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 during and after procedures using these devices… There have been thirteen reported injuries and four reports of death related to the 027 Compatible Pipeline Vantage Embolization Device. There have been four reported injuries and no reports of death related to the 021 Compatible Pipeline Vantage Embolization Device,” the FDA stated in its updated notice.