Medtronic DxTerity — Class III medical device recall Z-3253-2018
Terminated recall by Medtronic Vascular, reported 2018-10-03, distributed in CA, IA, NE, TN, TX, VA, WA. Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French
| Recall number | Z-3253-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Danvers, MA, United States |
| Recall initiated | 2018-08-16 |
| Classified | 2018-09-26 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2021-05-07 |
| Distributed | CA, IA, NE, TN, TX, VA, WA |
| Countries outside the US | JM, NZ, TH |
| Quantity | 250 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20643169738717 |
| Lot numbers | 60068186 |
| Model numbers | U5TRAN35 |
Product
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Reason for recall
Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.
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-3253-2018. 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.