Recall Z-3227-2017— Medtronic Vascular, Inc.

Name: FDA recall Z-3227-2017
Creator: U.S. Food and Drug Administration
Published: 2017-09-13

Class II · Terminated

Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2017-09-13, terminated 2020-05-18. It names one FDA 510(k) clearance: K171427. 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.. Reason: 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..

Recalling firm: Medtronic Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-13
Terminated: 2020-05-18
Firm location: Santa Rosa, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K171427 — Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc.·cleared 2017-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.