Medtronic 6F Launcher Guide Catheter 100cm EBU 3 — Class II medical device recall Z-1247-2021
Terminated recall by Medtronic Vascular, reported 2021-03-17, distributed nationwide. Sterility may be compromised due to an unsealed pouch
| Recall number | Z-1247-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Danvers, MA, United States |
| Recall initiated | 2021-01-15 |
| Classified | 2021-03-11 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2023-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 10 units |
| Reason classes | sterility |
| Lot numbers | 220772561, 220772562 |
| Model numbers | LA6EBU375 |
Product
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Reason for recall
Sterility may be compromised due to an unsealed pouch
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-1247-2021. 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.