Medtronic DxTerity Diagnostic Catheter — Class II medical device recall Z-1479-2018
Terminated recall by Medtronic Vascular, reported 2018-05-02. The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than th
| Recall number | Z-1479-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Danvers, MA, United States |
| Recall initiated | 2018-03-13 |
| Classified | 2018-04-20 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2021-05-07 |
| Countries outside the US | AT, CA, DE, RO, SI |
| Quantity | 855 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20643169689309 |
| Lot numbers | 60074805 |
| Model numbers | DXT5JL40 |
Product
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Reason for recall
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
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-1479-2018. 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.