NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 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 units of the NC TREK RX Coronary Dilatation Catheter (4.00 X 20MM) because the balloon may exhibit difficulty or inability to deflate. The affected devices were distributed worldwide, including throughout the United States and numerous other countries. The recalled lot numbers are 90727G1, 91004G1, 90830G1, 91028G1, and 90923G1, identifiable by part number 1012453-20 and GTIN 08717648152085.
The recall affects a total of 13,891 units in the US and 25,796 units distributed outside the US. The source document does not specify a remedy or instructions for what consumers should do regarding this recall.
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: 08717648152085 Part Number: 1012453-20 Lot Numbers: 90727G1 91004G1 90830G1 91028G1 90923G1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.