NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Check against the official notice below — it lists the full affected range.
Abbott Vascular is recalling the NC Traveler RX 4.0 X 12MM Coronary Dilatation Catheter (Part Number 1013157-12, Lot Number 90812G1) because the device may have difficulty or inability to deflate the balloon. A total of 791 units were distributed worldwide outside the United States, including in countries such as Canada, Mexico, Brazil, Australia, and numerous others across Europe, Asia, the Middle East, and Africa. Zero units were distributed in the United States.
The source document does not specify a remedy or recommended action for affected consumers.
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 791 Traveler (0 US and 791 OUS) Lot/code info: Device Identifier/GTIN: 08717648195990 Part Number: 1013157-12 Lot Numbers:90812G1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.