St. Jude Medical: Device Recall

Recall #Z-2348-2024 · 04/30/2024

Class II: Risk

Recall Details

Recall Number: Z-2348-2024
Classification: Class II
Product Type: Device
Recalling Firm: St. Jude Medical
Status: Ongoing
Date Initiated: 04/30/2024
Location: Minnetonka, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 129 units

Reason for Recall

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

Product Description

St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

Distribution Pattern

US and Canada

Other Recalls by St. Jude Medical

Class II: Risk 02/03/2025

Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
Class II: Risk 11/06/2024

Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
Class II: Risk 10/05/2024

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Class II: Risk 10/05/2024

As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

View all recalls by St. Jude Medical →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.