FDA: Class I recall of Medtronic’s MindFrame Capture LP revascularization device

Editor's Note

The Food and Drug Administration (FDA) on May 18 identified the recall of Medtronic’s MindFrame Capture LP revascularization device as Class I, the most serious.

Medtronic is recalling the device because there is a risk of the delivery wire breaking or separating during use.

The clot retriever, which is intended to restore blood flow or remove clots in a blood vessel in the brain during a stroke, could be left inside the patient’s bloodstream, leading to further complications such as bleeding, further blockage of blood vessels, more severe stroke symptoms, or death.

The distribution dates for the device were March 18, 2016 to January 17, 2018.