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 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters, specifically the 5.00 x 15mm model (Part Number 1012455-15). The recall involves a total of 39,687 units, including 13,891 units in the United States and 25,796 units distributed worldwide.
The recall was initiated because the coronary dilatation catheters may exhibit difficulty or inability to deflate the balloon. The 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 affected lot numbers are 90806G1, 91022G1, 90806G2, and 91025G1. The Device Identifier/GTIN is 08717648152153. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 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
- 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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