Recall Z-3227-2017 ยท OTD Endovascular Suturing System
Medtronic Vascular, Inc.
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
| Date | Sep 13, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | The firm initiated their recall on September 13, 2017, by letter. The letter requested the consignee take the following actions: "1. Identify and quarantine all unused affected product as listed in your inventory. 2. Return all unused affected list product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-854-3570 to initiate a product return and credit. Your local Medtronic Representative can assist you in the return and replacement of this product as necessary. 3. Complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367- |
| Quantity | 20 units |
| Distribution | US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette Medtronic Vascular, Inc., Jun 13, 2017 |