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

Recalled February 26, 2020 · FDA recall Z-1141-2020 · Abbott Vascular

Hazard

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. · FDA Class I

Units

Total 791 Traveler (0 US and 791 OUS)

Sold at

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 Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

Description

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

Product

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.

Manufacturer(s)

Abbott Vascular

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →