NC TRAVELER Coronary Dilatation Catheter — Class I medical device recall Z-1140-2020
Terminated recall by Abbott Vascular, reported 2020-02-26, distributed nationwide. Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
| Recall number | Z-1140-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Vascular, Temecula, CA, United States |
| Recall initiated | 2020-01-29 |
| Classified | 2020-02-14 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2024-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LB, LK, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PK, PL, PT, RO, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 08717648195983 |
| Lot numbers | 91010G1 |
| Model numbers | 1013157-08 |
Product
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Reason for recall
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1140-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.