NC TREK Coronary Dilatation Catheter — Class I medical device recall Z-1138-2020
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-1138-2020 |
|---|---|
| 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 | 08717648152153 |
| Lot numbers | 90806G1, 90806G2, 91022G1, 91025G1 |
| Model numbers | 1012455-15, 2.00, 5.00 |
Product
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)
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-1138-2020. 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.