Class II

Medical Device Recall: St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

St. Jude Medical · April 30, 2024

Reason for Recall

One lot of product has dilators that are too short and will not extend outside the introducer sheath.

Distribution

US and Canada

Quantity Affected

129 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2348-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

St. Jude Medical Medical Device Recall: St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 | SafeCheck