NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 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 NC TREK Coronary Dilatation Catheters (model REF 1012455-120, 5.00 X 20MM) due to a hazard where the balloon may exhibit difficulty or inability to deflate. The affected devices were distributed worldwide, including nationwide in the US and in numerous countries. A total of 39,687 units have been recalled, comprising 13,891 units distributed in the US and 25,796 units distributed outside the US. The recalled devices are identified by Part Number 1012455-20 and Lot Numbers 91010G1 and 91026G1.
The source document does not specify a remedy or any actions affected consumers should take.
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: 08717648152160 Part Number: 1012455-20 Lot Numbers:91010G1 91026G1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.