Abbott NC TREK Coronary Dilatation Catheters Recalled for Balloon Deflation Issues
Abbott Vascular is recalling NC TREK 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 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 identifies the agency classification 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, specifically the 4.50 x 20mm BDC model (Part Number 1012454-20). The recall involves a total of 39,687 units, with 13,891 distributed in the United States and 25,796 distributed outside the US. The affected lot numbers are 90801G1, 91018G1, 90809G1, and 91021G1.
The recall was initiated because the coronary dilatation catheters may exhibit difficulty or an inability to deflate the balloon. This device 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 FDA Class I by the U.S. Food and Drug Administration. The distribution was worldwide, including the United States and numerous other countries. Healthcare providers and patients should contact Abbott Vascular for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM 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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