Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used in coronary procedures where a failure to deflate could cause harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters, Reference 1012453-20, due to a defect where the balloon may exhibit difficulty or inability to deflate. The recall covers a total of 39,687 units, including 13,891 units distributed in the United States and 25,796 units distributed outside the United States.
The affected devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, balloon dilatation of a coronary artery occlusion in patients with ST-segment elevation myocardial infarction, and balloon dilatation of a stent after implantation. The recall includes specific lot numbers: 90801G1, 90925G1, 90812G1, 91010G2, 90818G1, 91022G1, 90818G2, 91025G1, 90904G1, 91101G1, and 90912G1.
Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of the affected devices. The source text does not report any specific injuries or illnesses associated with this defect.
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 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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