Reported Sep 6, 2017 · Terminated
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Fogarty Adherent Clot Catheter Model Numbers 1408010
- and 140806 Product UsageThe 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
- Lot codes and dates
- Lots 60439817 and 60439818
- Amount recalled
- 200 units
Where it was sold
- Nationwide
- DE
Why it was recalled
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
This product could cause temporary or reversible health problems — stop using it.
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