Device recall
Z-3227-2017: Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF…
FDA device recall · Class II · Medtronic Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-3227-2017 |
|---|---|
| Recall event | 78127 |
| 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… |
| Product code | OTD |
| Recalling firm | Medtronic Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2020 |
| 510(k) numbers | K171427 |
| FEI number | 3001452571 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database