FDA designates Class 1 recall for embolization devices

Editor's Note

Endovascular devices used to block aneurysm blood flow are the subject of the latest recall to be designated Class 1—the most severe designation indicating serious risk of injury or death—by the US Food and Drug Administration (FDA).

As detailed in the agency’s March 18 announcement, Medtronic Neurovascular is recalling the 027 Compatible Pipeline Vantage Embolization device and updating use instructions for the 021 Compatible device. Both moves were motivated by risk of thrombosis, stroke, or death due to incomplete wall apposition and/or braid deformation during and after procedures. Thirteen injuries and four deaths have been reported related to the 027 Compatible model; four injuries and no deaths have been reported related to the 021 Compatible model.

Instructions for users of the devices, detailed in full in the announcement, advise returning all unused 027 devices and reading updated instructions before using 021 devices. Other details include catalog and serial numbers and advice for patients.