Recall archive / FDA device enforcement
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 — FDA record Z-2348-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 30, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- St. Jude Medical
- Quantity
- 129 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2348-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 05414734206099, Lot Number 10071090 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US and Canada
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 24, 2024
- Recall initiation date
- Apr 30, 2024
- Center classification date
- Jul 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.