Abbott NC Trek RX Coronary Dilatation Catheter Recall for Sheath Removal Issues
Abbott Vascular is recalling NC Trek 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 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 indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or the death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 (Severe) or higher.
Plain-English summary
Abbott Vascular is recalling the NC Trek RX Coronary Dilatation Catheter, including multiple part numbers and lot numbers, due to a potential defect in the protective balloon sheath. The recall covers 449,661 units total, with 132,040 units distributed in the United States and the remainder distributed worldwide.
The identified lots may exhibit difficulty in removing the protective balloon sheath. This issue can result in problems with inflating or deflating the balloon during use. The recall is classified as Class I by the FDA.
Healthcare providers and facilities should stop using the affected catheters and contact Abbott Vascular for instructions on how to return or dispose of the products.
The recalled product
- Product
- NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12…
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
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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