NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM 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 Coronary Dilatation Catheters (model REF 1012453-08, 4.00 X 8MM) because the balloon may exhibit difficulty or inability to deflate during use. The affected devices were distributed worldwide, including throughout the United States and numerous other countries. A total of 39,687 units have been recalled, consisting of 13,891 units distributed in the US and 25,796 units distributed outside the US. The recalled lot numbers are 90731G1, 90921G1, 90808G1, 90928G1, 90826G1, 91003G1, 90906G1, 91017G1, and 91106G1.
The NC TREK RX Coronary Dilatation Catheter is used for balloon dilatation of stenosed coronary arteries. This recall affects devices with part number 1012453-08 and device identifier/GTIN 08717648152054. The source document does not specify a remedy for affected consumers or healthcare facilities.
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:08717648152054 Part Number: 1012453-08 Lot Numbers: 90731G1 90921G1 90808G1 90928G1 90826G1 91003G1 90906G1 91017G1 91106G1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.