Abbot Vascular is recalling the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters, balloon diameters 4.0mm, 4.5mm and 5.0mm because the balloons from the impacted lots may not deflate as intended. This issue is due to weaker material close to the balloon bond resulting from excessive exposure to heat during manufacturing. The FDA has identified this as a Class I recall because use of these devices may cause serious injuries or death.
Use of these devices may cause serious adverse health consequences, such as prolonged cardiac ischemia (reduced blow flow to the heart), air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and additional surgery that could lead to post-operative complications, including death.
The NC TREK RX Coronary Dilatation Catheter is indicated for use in the following cardiac (heart) procedures:
- 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).
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
