Abbott NC Traveler RX Coronary Dilatation Catheter Recall for Balloon Sheath Issues
Abbott Vascular is recalling NC Traveler RX Coronary Dilatation Catheters because the protective balloon sheath may be difficult to remove, potentially affecting balloon inflation or deflation.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Abbott Vascular is recalling specific lots of NC Traveler RX Coronary Dilatation Catheters. The recall involves 449,661 units total, with 132,040 units distributed in the United States and the remainder distributed worldwide.
The recall is due to a defect where the protective balloon sheath may be difficult to remove. This issue can result in problems with inflating or deflating the balloon. The affected part numbers include 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12, 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, and 1013157-15.
The FDA has classified this as a Class I recall. Healthcare providers and facilities should stop using the affected devices and contact Abbott Vascular for instructions on how to return or replace them.
The recalled product
- Product
- NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08…
- 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 3 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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