Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters, specifically the NC TREK RX 5.00 X 20MM BDC model (Part Number 1012455-20, Lot Numbers 91010G1 and 91026G1). The recall involves a total of 39,687 units, with 13,891 distributed in the United States and 25,796 distributed internationally.
The recall is being conducted because the coronary dilatation catheters may exhibit difficulty or inability to deflate the balloon. This device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, balloon dilatation of a coronary artery occlusion, and balloon dilatation of a stent after implantation.
The affected products were distributed worldwide, including in the United States and numerous countries across Africa, Asia, Europe, and the Americas. Healthcare providers and patients who have used or may have used these specific lot numbers should contact Abbott Vascular or their medical provider for further instructions.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by Abbott Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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