Device product
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.
Z-1144-2020
Product summary
- Firm
- Abbott Vascular
- Event
- Event 84826
- Status
- Terminated
- Classification
- Class I
- Quantity
- Total 791 Traveler (0 US and 791 OUS)
- Official record key
device-enforcement:Z-1144-2020
Official wording
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Code information: Device Identifier/GTIN: 08717648196034 Part Number: 1013158-12 Lot Numbers:90813G1
Distribution pattern: 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
Derived failure modes
-
Unknown
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.