Who May be Affected
- 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.
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).