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.
Recall
- Recall Number
- Z-3077-2017
- Event Number
- 77802
- Firm
- Edwards Lifesciences, LLC
- FEI Number
- 2015691
- Product Code
- DXE
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- July 6, 2017
- Terminated
- October 17, 2018
- Address
- 1 Edwards Way, Irvine, CA, 92614-5688
Description
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.
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
Recall notification letters were sent to affected customers on 7/6/2017. The recall notice included a response form and instructed consignee to return any unused devices..
Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI
200 units