Abbott Vascular Recalls NC TREK Coronary Dilatation Catheters
Abbott Vascular is recalling NC TREK RX Coronary Dilatation Catheters because the balloon may have difficulty or inability 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 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 FDA classified this recall as Class I, which is defined by the rubric as Severe (score 4). A balloon that cannot deflate in a coronary artery poses a significant risk of serious injury or death.
Plain-English summary
Abbott Vascular is voluntarily recalling specific lots of the NC TREK RX Coronary Dilatation Catheter. The product is indicated for balloon dilatation of stenotic coronary arteries, occlusions, or stents to improve myocardial perfusion or restore flow.
The recall was initiated because the catheters may exhibit difficulty or inability to deflate the balloon. This defect could prevent the device from being withdrawn after use.
A total of 39,687 units are affected, including 13,891 distributed in the United States and 25,796 distributed outside the US. The distribution pattern includes countries across North America, South America, Europe, Asia, Africa, and Oceania. Affected lot numbers include 90819G1, 90927G1, 90819G2, 90930G1, 90916G1, 91031G1, and 90916G2.
Healthcare providers should stop using the affected devices immediately. Patients who have received these devices should contact their healthcare provider for guidance.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM 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
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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