FDA Device recall Z-1142-2020
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter…
- FDA Device
- Class I
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class I recall of NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter… by Abbott Vascular, citing coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1142-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-01-29 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Vascular |
| Distribution | n/a |
Product
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Reason
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Identifiers
| code_info | Device Identifier/GTIN: 08717648196003 Part Number: 1013157-15 Lot Numbers:91102G1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1142-2020%22
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