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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 Hel
Recalled October 4, 2017 · FDA recall Z-3227-2017 · Medtronic Vascular
Hazard
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. · FDA Class II
Units
20 units
Sold at
US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.
Description
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.
Product
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.
Manufacturer(s)
Medtronic Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →