Abbott NC Traveler Coronary Dilatation Catheter Recall 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.
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 recall is classified as FDA Class I, which per the rubric mandates a score of at least 4 (Severe) due to the potential for serious adverse health consequences.
Plain-English summary
Abbott Vascular is recalling the NC Traveler Coronary Dilatation Catheter (REF 1013157-08, NC Traveler RX 4.0 X 8MM) due to a potential defect where the balloon may exhibit difficulty or inability to deflate. The recall covers 791 units distributed worldwide, with zero units distributed in the United States.
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States. The affected units were distributed in various countries outside the US, including Canada, the United Kingdom, and Australia. The specific lot number for the recalled units is 91010G1.
Healthcare providers and patients should stop using the affected catheters and contact Abbott Vascular for further instructions. 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 recalled product
- Product
- NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 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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