St — Class II medical device recall Z-2348-2024
Ongoing recall by St. Jude Medical, reported 2024-07-24. One lot of product has dilators that are too short and will not extend outside the introducer sheath.
| Recall number | Z-2348-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Minnetonka, MN, United States |
| Recall initiated | 2024-04-30 |
| Classified | 2024-07-12 |
| Reported by FDA | 2024-07-24 |
| Countries outside the US | CA |
| Quantity | 129 units |
| UPC / GTIN / UDI-DI | 05414734206099 |
| Lot numbers | 10071090 |
| Model numbers | 408309 |
Product
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Reason for recall
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
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-2348-2024. 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.