—#157926

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.

FDA product code: DXE — Catheter, Embolectomy
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K901625
Affected lot / code info: Lots 60439817 and 60439818

Why it was recalled

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

Root cause (FDA determination)

Packaging

Action the firm took

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..

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

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

Timeline

Recall initiated: 2017-07-06
Terminated: 2018-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157926. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.