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
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