NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 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 (5.00 X 8MM) because the balloon may exhibit difficulty or inability to deflate. The affected devices have part number 1012455-08 and lot numbers 90918G1, 91001G1, and 90930G1. A total of 39,687 units have been distributed worldwide, including 13,891 units in the United States and 25,796 units outside the United States across numerous countries.
The recall affects coronary dilatation catheters indicated for balloon dilatation procedures. The source document does not specify what action affected consumers should take in response to 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: 08717648152139 Part Number: 1012455-08 Lot Numbers: 90918G1 91001G1 90930G1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.