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 myocardial perfusion b) ball
Check against the official notice below — it lists the full affected range.
Abbott Vascular is recalling NC TREK RX 5.00 X 15MM Coronary Dilatation Catheters due to a hazard where the balloon may exhibit difficulty or inability to deflate. The recalled devices were distributed worldwide, including nationwide in the United States and in numerous countries overseas. A total of 39,687 units have been recalled, including 13,891 units distributed in the US and 25,796 units distributed outside the United States. The affected lot numbers are 90806G1, 91022G1, 90806G2, and 91025G1, identified by part number 1012455-15 and GTIN 08717648152153.
The NC TREK RX Coronary Dilatation Catheter is designed for balloon dilatation procedures. The FDA recall record does not specify a remedy or recommended action for consumers who may have affected devices.
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: 08717648152153 Part Number: 1012455-15 Lot Numbers:90806G1 91022G1 90806G2 91025G1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.