FDA Device recall Z-2348-2024
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 by St Jude Medical, citing one lot of product has dilators that are too short and will not extend outside the introducer sheath.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2348-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-30 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | St Jude Medical |
| Distribution | n/a |
Product
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Reason
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Identifiers
| code_info | UDI/DI 05414734206099, Lot Number 10071090 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2348-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.