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Recall Observatory FDA recall evidence

Device 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.

Z-3077-2017

July 06, 2017

Class II

Product summary

Firm
Edwards Lifesciences, LLC
Event
Event 77802
Status
Terminated
Classification
Class II
Quantity
200 units
Official record key
device-enforcement:Z-3077-2017

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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