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.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon."
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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