Edwards Fogarty Clot Catheters: 6mm Balloon Size Risk
Edwards Lifesciences recalls Fogarty Adherent Clot Catheters with 6mm balloon size instead of 10mm. This may cause incomplete clot removal. Affected models 1408010 and 140806.
Lower-risk recall
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
Contact the company
What happened, in plain English
Edwards Lifesciences recalls two specific models of Fogarty Adherent Clot Catheters due to a smaller balloon size (6mm instead of 10mm) that could lead to incomplete clot removal. This affects medical use cases where precise clot extraction is critical. Read more at govinfonow.com/recall/73458-edwards-fogarty-clot-catheters-6mm-balloon-size-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73458-edwards-fogarty-clot-catheters-6mm-balloon-size-risk · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3077-2017
Cite this page
“Edwards Fogarty Clot Catheters: 6mm Balloon Size Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73458-edwards-fogarty-clot-catheters-6mm-balloon-size-risk. Based on FDA recall #Z-3077-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3077-2017%22&limit=1).
Why it’s dangerous
The catheter's balloon is designed to measure 10mm but actually measures 6mm. This smaller size may not effectively remove clots, potentially leading to incomplete clot extraction during procedures.
Who’s affected
Healthcare professionals using these catheters for clot removal procedures. Patients receiving these catheters during medical treatments are at risk if the smaller balloon size causes incomplete clot removal.
How to tell if you have this one
Check for model numbers 1408010 or 140806 on the catheter packaging or device. The product was sold with lots 60439817 and 60439818.
- Brand
Edwards Lifesciences- Category
Medical device
What to do — step by step
Check Model Number
Look for model numbers 1408010 or 140806 on the catheter packaging or device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 15 months 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.
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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-3077-2017 (July 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3077-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.