Teleflex is initiating a voluntary field safety corrective action due to reports received indicating PTD tip separation during use. If the tip separates during use, clinicians may exercise their medical judgment to either retrieve endovascularly with a snare device or with a minor surgical procedure, or elect not to retrieve the tip given the recognition that embolism of a small and inert tip may be less likely to be harmful than extraordinary attempts to retrieve said tip. Partial or full embolization of foreign material into the arterial or venous circulation is possible, potentially leading to vascular complications, including but not limited to mechanical obstruction of an artery or vein, arterial or venous thrombosis, ischemia, or infarction in the territory subtended by an obstructed or thrombosed artery (including pulmonary embolism and infarction), and remotely, endovascular infection. the consequences of embolizing foreign material into the peripheral or pulmonary circulation or components thereof are substantially determined by the size of the embolus. Clinicians may also elect to exclude the embolus from the circulation by trapping the embolus outside a newly deployed stent. Recall start date: Jan 12, 2022
RecallTracker