Abbott NC TREK Coronary Dilatation Catheter Recall for 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 severity score of at least 4 per the rubric.
Plain-English summary
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters, specifically the 5.00 x 12mm BDC model (Part Number 1012455-12). The recall involves a total of 39,687 units, including 13,891 units distributed in the United States and 25,796 units distributed internationally.
The recall is being conducted because the coronary dilatation catheters may exhibit difficulty or inability to deflate the balloon. The affected lot numbers are 90918G1, 90930G1, 90926G1, and 91031G1.
The devices were distributed worldwide, including in the United States and numerous countries across the Americas, Europe, Asia, Africa, and the Middle East. Healthcare providers and facilities should stop using the affected devices and contact Abbott Vascular for further instructions.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM 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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