Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 4, 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 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 e
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Vascular, Inc. recalled Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, … - a moderate-severity action.
Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, … was recalled by Medtronic Vascular, Inc. in October 4, 2017. Reason: It was determined that the deflection length indicated on the Guide catheter handle does not match the label …. Check the official notice for the remedy. Verify recall #Z-3227-2017 with the FDA Devices before acting.
The recall
Medtronic Vascular, Inc. issued this moderate-severity FDA Devices recall-It was determined that the deflection length indicated on the Guide catheter handle does not match the label ….
- Moderate
- severity level
- 20 units
- affected scope
- Class II
- classification
- October 4, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3227-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3227-2017) was formally reported on October 4, 2017, with the manufacturer initiating the action on September 13, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Vascular, Inc. is listed as the recalling firm, operating out of Santa Rosa, CA. Federal records list the affected scope as 20 units.
The documented reason for this recall is: 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 data in the federal record shows the product reached: US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
20 units
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3227-2017 |
| Date reported | October 4, 2017 |
| Date initiated | September 13, 2017 |
| Recalling firm | Medtronic Vascular, Inc. |
| Firm location | Santa Rosa, CA |
| Affected scope | 20 units |
| Distribution | US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3227-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Vascular, Inc.. Units affected: 20 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 4, 2017. Severity: Moderate. Recall number: Z-3227-2017.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3227-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 4, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.