Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm — Class II medical device recall Z-3227-2017
Terminated recall by Medtronic Vascular, Inc., reported 2017-10-04, distributed in AZ, CA, FL, GA, MA, MI, MN, NH. It was determined that the deflection length indicated on the Guide catheter handle does not match the label o
| Recall number | Z-3227-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2017-09-13 |
| Classified | 2017-09-27 |
| Reported by FDA | 2017-10-04 |
| Terminated | 2020-05-18 |
| Distributed | AZ, CA, FL, GA, MA, MI, MN, NH |
| Quantity | 20 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 00763000006655, 00763000006679 |
| Lot numbers | 0008674156, 0008674157 |
| Model numbers | HG-18-90-42 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3227-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.