Abbott Vascular: NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution i

Is my product affected?

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

• UPC 08717648195983

Check against the official notice below — it lists the full affected range.

What happened

Abbott Vascular has recalled the NC Traveler RX 4.0 X 8MM Coronary Dilatation Catheter (Part Number 1013157-08, Lot Number 91010G1) because the device may experience difficulty or inability to deflate the balloon during use. A total of 791 units were distributed worldwide outside the United States to countries including Canada, Mexico, Australia, Brazil, China, Japan, India, and numerous European and Asian nations.

The recall notice does not specify a remedy or corrective action for consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Details from the source

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: 08717648195983 Part Number: 1013157-08 Lot Numbers:91010G1

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls