Abbott NC TREK Coronary Dilatation Catheter Recall for Balloon Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.
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 recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Abbott Vascular is recalling the NC TREK Coronary Dilatation Catheter (REF 1012453-20) due to a defect where the balloon may exhibit difficulty or inability to deflate. The recall includes 39,687 units, comprising 13,891 units in the United States and 25,796 units in other countries. The affected lot numbers are 90801G1, 90925G1, 90812G1, 91010G2, 90818G1, 91022G1, 90818G2, 91025G1, 90904G1, 91101G1, and 90912G1.
The NC TREK RX Coronary Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, balloon dilatation of a coronary artery occlusion, and balloon dilatation of a stent after implantation. 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.
Healthcare providers and patients should stop using the affected devices and contact Abbott Vascular for further instructions. The recall covers worldwide distribution, including the United States and numerous international locations.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving…
- 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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