Medtronic Vascular, Inc. recalls Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-F…

Recall date

September 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3227-2017

FDA classification

Class II

Brand / firm

Medtronic Vascular, Inc.

Sold / distributed

US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.

Why it was recalled

It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients who endovascular grafts have exhibited migration or endoleak, or are at risk for such complications, in whom augmented radial fixation and or sealing is required or regain or maintain adequate aneurysm exclusion.