Abbott NC TREK Coronary Dilatation Catheters Recalled for 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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters (REF 1012455-08) due to a potential defect where the balloon may exhibit difficulty or inability to deflate. The recall includes 39,687 units, consisting of 13,891 units in the United States and 25,796 units outside the United States.
The affected devices are identified by Part Number 1012455-08 and Lot Numbers 90918G1, 91001G1, and 90930G1. 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 U.S. Food and Drug Administration. The devices were distributed worldwide, including in the United States and numerous international markets. Healthcare providers should stop using the affected devices and contact Abbott Vascular for further instructions.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 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 myoc
- 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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