Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (balloon deflation failure) that poses a risk of harm during a procedure, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Abbott Vascular is recalling the NC Traveler Coronary Dilatation Catheter, Reference 1013157-12, Lot 90812G1. The recall involves 791 units distributed worldwide, with zero units distributed in the United States. The product is not cleared for commercial distribution in the US.
The recall was initiated because the coronary dilatation catheters may exhibit difficulty or inability to deflate the balloon. This defect could impact the intended use of the medical device during a procedure.
Healthcare providers and facilities that have received these devices should stop using them and contact Abbott Vascular for further instructions. Consumers are not affected as the product was not distributed in the United States.
The recalled product
- Product
- NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 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
- 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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