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 high-risk medical device (coronary catheter) with a functional defect (balloon deflation failure) that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Abbott Vascular is recalling the NC Traveler Coronary Dilatation Catheter (REF 1013158-08, Lot 90812G1). The recall involves 791 units, all of which were distributed outside the United States. The device is not cleared for commercial distribution in the US.
The recall is due to a defect where the catheter's balloon may exhibit difficulty or inability to deflate. This issue could affect the intended use of the device during coronary procedures.
Healthcare providers and patients should contact Abbott Vascular for further instructions regarding the affected devices.
The recalled product
- Product
- NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM 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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