Recall Z-3077-2017— Edwards Lifesciences, LLC

Name: FDA recall Z-3077-2017
Creator: U.S. Food and Drug Administration
Published: 2017-07-06

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2017-07-06, terminated 2018-10-17. It names one FDA 510(k) clearance: K901625. 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..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-07-06
Terminated: 2018-10-17
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K901625 — FOGARTY ARTERIAL EMBOLECTOMY II CATHETERBaxter Healthcare Corp·cleared 1990-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.