The PR mentions the FDA recalls, but I agree, it could explain the clinical complications particles cause I'm the blood stream. Blood tends to clot on foreign objects, so even tiny particles cause clotting complications. JNJ's Cypher stent was removed from the market because the coating was flaking off and causing complications.
Although complications are comparatively far fewer, interventional cardiac catheterization has its own set of complications that may include arterial or venous thrombosis, disseminated intravascular coagulation (DIC), foreign body embolization, phlebitis, endotoxemia, cardiac dysrhythmias, infection and restenosis. 1,3 These complications can be caused by the catheter itself, the balloon (or fragments thereof), any device being implanted such as a coil or stent, or, of course, poor technique. Complications may also be caused or exacerbated by foreign debris deposited on the inside or outside surfaces of the catheter and subsequently co-inserted into the bloodstream. Because of the direct vascular insertion and extensive surface area exposed, minimally invasive procedures conducted through the circulatory system may actually place the patient at greater risk of particulate-related complications. Investigators have demonstrated that contamination with lint, powder and other particulates may occur during procedural preparation or actual surgery. However, rarely are embolic clots, inflamed vascular walls or overgrown neointimal areas examined histologically to investigate the possible presence of microscopic condensation nuclei. Where histopathologic investigations have been performed, the results have been very illuminating and provide evidence-based precautionary recommendations for avoiding foreign debris-associated complications during cardiac catheterization as well as any other form of vascular catheterization.