St. Jude Medical: Medical Device Recall in 2024 - (Recall #: Z-2348-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

Product Classification:

Class II

Date Initiated: April 30, 2024

Date Posted: July 24, 2024

Recall Number: Z-2348-2024

Event ID: 94613

Reason for Recall:

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

Status: Ongoing

Product Quantity: 129 units

Code Information:

UDI/DI 05414734206099, Lot Number 10071090

Distribution Pattern:

US and Canada

Voluntary or Mandated:

Voluntary: Firm initiated