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 myocardial perfusion b) bal
Check against the official notice below — it lists the full affected range.
Abbott Vascular is recalling 39,687 NC TREK RX 4.50 X 20MM Coronary Dilatation Catheters (Part Number 1012454-20) distributed worldwide, including 13,891 units in the US and 25,796 units outside the US. The affected devices are from lot numbers 90801G1, 91018G1, 90809G1, and 91021G1. These catheters are used for balloon dilatation procedures to treat coronary stenosis.
The devices may exhibit difficulty or inability to deflate the balloon after use. The FDA record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Reason for recall: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Distribution: Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federa Quantity: Total 39687 NC TREK units (13891 US and 25796 OUS) Lot/code info: Device Identifier/GTIN: 08717648152122 Part Number: 1012454-20 Lot Numbers: 90801G1 91018G1 90809G1 91021G1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.