Abbott NC TREK Coronary Dilatation Catheter Recall 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.
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 per the rubric requires a minimum score of 4 (Severe) due to the reasonable probability of serious adverse health consequences.
Plain-English summary
Abbott Vascular is recalling the NC TREK Coronary Dilatation Catheter (REF 1012453-15) 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 outside the US. The affected lot numbers are 90815G1, 91008G1, 90816G1, 91009G1, 90828G1, 91020G1, 90904G1, 91026G1, 90920G1, 91109G1, 90926G1, and 91117G1.
The device is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts, coronary artery occlusions in patients with ST-segment elevation myocardial infarction, and post-implantation stent dilatation. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of the device will cause serious adverse health consequences or death.
Healthcare providers and facilities should stop using the affected catheters and contact Abbott Vascular for instructions on return or replacement. Patients who have had these catheters used should consult their healthcare provider if they experience any complications.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 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
- Category
- Medical Device — Cardiovascular
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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