FDA Device recall Z-3077-2017
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectiv…
- FDA Device
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectiv… by Edwards Lifesciences, citing the diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3077-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-06 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
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
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
Identifiers
| code_info | Lots 60439817 and 60439818 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3077-2017%22
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