Edwards Lifesciences, LLC: Medical Device Recall in 2017 - (Recall #: Z-3077-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 6, 2017

Date Posted: September 6, 2017

Recall Number: Z-3077-2017

Event ID: 77802

Reason for Recall:

The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.

Status: Terminated

Product Quantity: 200 units

Code Information:

Lots 60439817 and 60439818

Distribution Pattern:

Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI

Voluntary or Mandated:

Voluntary: Firm initiated