Patients who undergo cardiac procedures involving the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters.
Health care providers and hospitals using the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters.
What to Do
Immediately stop using affected devices from the lots affected by this recall.
Review your inventory, complete, and return the attached Effectiveness Check Form.
Return all unused affected product to Abbott Vascular.
Share the notification with other relevant personnel in your organization.
Device Use:
Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart.
balloon dilatation of the abnormal narrowing portion of a coronary artery or bypass graft, for the purpose of improving myocardial perfusion
balloon dilatation of a coronary artery occlusion, to restore coronary flow in patients who have had a type of heart attack, known as myocardial infarction – specifically patients with ST-segment elevation, which refers to the flat section of an electrocardiogram (ECG) reading and represents the interval between heartbeats.
balloon dilatation of a stent after implantation (balloon models 4.00 mm – 5.00 mm only).
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