Abbott NC TREK Coronary Dilatation Catheter Recall for Balloon Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 according to the rubric.
Plain-English summary
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters, specifically the 4.00 x 20mm BDC model (Part Number 1012453-20). The recall involves 39,687 units distributed worldwide, including 13,891 units in the United States and 25,796 units in other countries.
The recall is being conducted because the coronary dilatation catheters may exhibit difficulty or inability to deflate the balloon. The affected lot numbers are 90727G1, 91004G1, 90830G1, 91028G1, and 90923G1.
Healthcare providers and patients should stop using the affected devices and contact Abbott Vascular for further instructions or replacement.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 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…
- 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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