# FDA recall Z-3227-2017

> **Medtronic Vascular, Inc.** · Class II · device recall initiated 2017-09-13.

## 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.

## Distribution

US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.

## Key facts

- **Recall number:** Z-3227-2017
- **Recalling firm:** Medtronic Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-13
- **Report date:** 2017-10-04
- **Termination date:** 2020-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Rosa, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3227-2017

## Citation

> AI Analytics. FDA recall Z-3227-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3227-2017. Source: US FDA. Licensed CC0.

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