Medtronic Heli-FX Guide Catheter Label Mismatch Recall
Medtronic recalls specific Heli-FX Thoracic EndoAnchor System guides due to mismatched deflection length labels on packaging versus actual product. This may affect medical procedures requiring precise catheter handling.
Lower-risk 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.
Contact the company
What happened, in plain English
Medtronic is recalling certain Heli-FX Thoracic EndoAnchor System guide catheters because the deflection length labeled on the packaging does not match the actual product. This mismatch could lead to incorrect catheter handling during medical procedures. Read more at govinfonow.com/recall/73027-medtronic-heli-fx-guide-catheter-label-mismatch-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/73027-medtronic-heli-fx-guide-catheter-label-mismatch-recall · Updated September 17, 2026 · FDA enforcement record: FDA #Z-3227-2017
Cite this page
“Medtronic Heli-FX Guide Catheter Label Mismatch Recall.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73027-medtronic-heli-fx-guide-catheter-label-mismatch-recall. Based on FDA recall #Z-3227-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3227-2017%22&limit=1).
Why it’s dangerous
The deflection length on the catheter handle does not match the label on the packaging or sterile packaging. This mismatch could result in incorrect catheter handling during medical procedures, potentially affecting the procedure's outcome.
Who’s affected
Healthcare professionals using the specific Heli-FX Guide catheters with the listed lot numbers and UDI codes. Patients undergoing procedures with these catheters may be at risk if the mismatch causes improper placement.
How to tell if you have this one
Check for the UDI code 00763000006679 or 00763000006655 and lot numbers 0008674156 or 0008674157 on the sterile packaging. The product is a Heli-FX Guide 42 mm catheter with reference number HG-18-90-42.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Packaging Labels
Verify the UDI code and lot number on the sterile packaging to confirm if the product is in the recalled range.
Where it went and when
Where it was distributed
Distributed in 8 states.
FDA distribution: “US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Georgia, Massachusetts, Michigan, Minnesota, New Hampshire.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall is for potential mismatch in labeling, which could affect procedure accuracy but does not indicate a risk of serious injury in normal use.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3227-2017 (September 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3227-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.