Medtronic Vascular, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3227-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 13, 2017

Date Posted: October 4, 2017

Recall Number: Z-3227-2017

Event ID: 78127

Reason for Recall:

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.

Status: Terminated

Product Quantity: 20 units

Code Information:

UDI 00763000006679, Lot Number 0008674156 UDI 00763000006655, Lot Number 0008674157

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated