Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806… — Class II medical device recall Z-3077-2017
Terminated recall by Edwards Lifesciences, LLC, reported 2017-09-06, distributed nationwide. The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
| Recall number | Z-3077-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2017-07-06 |
| Classified | 2017-08-25 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2018-10-17 |
| Distributed | Nationwide (US) |
| Quantity | 200 units |
| Lot numbers | 60439817, 60439818 |
| Model numbers | 1408010, 140806 |
Product
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric balloon. The device features a spiral-shaped, latex-covered stainless steel cable that assumes a corkscrew shape when retracted, greatly expanding the surface areas to entrap fibrous material. The device is 80 cm in length and is available in 4F-6F diameters.
Reason for recall
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
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-3077-2017. 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.