Abbott Vascular: NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution

Is my product affected?

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

• UPC 08717648196034

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

What happened

Abbott Vascular is recalling the NC Traveler RX 4.5 X 12MM Coronary Dilatation Catheter (Part Number 1013158-12, Lot Number 90813G1) because the balloon may have difficulty or be unable to deflate. A total of 791 units were distributed worldwide outside the United States to countries including Canada, Mexico, Australia, Brazil, and many others across Europe, Asia, Africa, and South America.

The source document does not specify a remedy or what affected consumers should do.

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: 08717648196034 Part Number: 1013158-12 Lot Numbers:90813G1

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