Abbott NC Traveler Coronary Dilatation Catheter Recalled for Deflation Issues
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.
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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it indicates a reasonable probability of serious adverse health consequences.
Plain-English summary
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters (REF 1013158-12, Lot 90813G1) due to a potential defect where the balloon may exhibit difficulty or inability to deflate. The recall involves a total of 791 units, all of which were distributed outside the United States. The source text explicitly states that the NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death. The specific hazard identified is the mechanical failure of the balloon to deflate, which could compromise the intended function of the coronary dilatation procedure.
Healthcare providers and facilities that may have received these devices should stop using them and contact Abbott Vascular for further instructions. Since the product is not cleared for commercial distribution in the US, US consumers are not expected to have access to this specific lot through standard commercial channels.
The recalled product
- Product
- NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
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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