Abbott Vascular: NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 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 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

• UPC 08717648196027

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 8MM Coronary Dilatation Catheter (Part Number 1013158-08, Lot Number 90812G1) because the device may have difficulty or inability to deflate the balloon. A total of 791 units were distributed worldwide outside the United States, with distribution to countries including Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Romania, Russian Federation, and Réunion.

The recall record does not specify a remedy or recommended course of action for consumers who may have received or used this device.

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: 08717648196027 Part Number: 1013158-08 Lot Numbers:90812G1

Source

Official record: FDA (Device enforcement) ↗

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

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