Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

NC TRAVELER Coronary Dilatation Catheter Recalled by Abbott Vascular Due to Coronary Dilatation Catheters may exhibit difficulty or inability...

Date: January 29, 2020
Company: Abbott Vascular
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Vascular directly.

Affected Products

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.

Quantity: Total 791 Traveler (0 US and 791 OUS)

Why Was This Recalled?

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

Where Was This Sold?

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

About Abbott Vascular

Abbott Vascular has 37 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report