Abbott Vascular recalls NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary…

Recall date

January 29, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1141-2020

FDA classification

Class I

Brand / firm

Abbott Vascular

Sold / distributed

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…

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.