Z-3077-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- July 6, 2017
- Termination Date
- October 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 units
Product 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.
Reason for Recall
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
Distribution Pattern
Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI
Code Information
Lots 60439817 and 60439818