Z-2348-2024 Class II Ongoing

Recalled by St. Jude Medical — Minnetonka, MN

Recall Details

Product Type
Devices
Report Date
July 24, 2024
Initiation Date
April 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
129 units

Product Description

St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

Reason for Recall

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

Distribution Pattern

US and Canada

Code Information

UDI/DI 05414734206099, Lot Number 10071090