FDA Device recall Z-3227-2017
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…
- FDA Device
- Class II
- terminated
- Published 2017-10-04
On 2017-10-04 the FDA classified a Class II recall of 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… by Medtronic Vascular, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3227-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-13 |
| Published | 2017-10-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Vascular |
| Distribution | AZ, CA, FL, GA, MA, MI, MN, NH |
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.
Identifiers
| code_info | UDI 00763000006679, Lot Number 0008674156 UDI 00763000006655, Lot Number 0008674157 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3227-2017%22
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