Abbott NC Traveler Coronary Dilatation Catheter Recall for Balloon Deflation Issues
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon 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 FDA classified this recall as Class I. Per the rubric, an FDA Class I recall must be scored at least 4 (Severe), as it indicates a reasonable probability of serious adverse health consequences.
Plain-English summary
Abbott Vascular is recalling the NC Traveler Coronary Dilatation Catheter (REF 1013157-15, NC Traveler RX 4.0 X 15MM) 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 notes that this device is not cleared for commercial distribution in the United States.
The hazard identified is the mechanical failure of the balloon to deflate, which could impact the intended use of the catheter during coronary dilatation procedures. 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.
Healthcare providers and facilities that have received these devices should stop using them and contact Abbott Vascular for instructions on return or destruction. Consumers are not directly affected as the product is prescription-only and not commercially distributed in the US.
The recalled product
- Product
- NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM 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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