St. Jude Medical: Device Recall

Recall Details

Recall Number

Z-0987-2025

Classification

Class II

Product Type

Device

Recalling Firm

St. Jude Medical

Status

Ongoing

Date Initiated

11/06/2024

Location

Atlanta, GA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

25 systems

Reason for Recall

Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

Product Description

Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.

Distribution Pattern

U.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/A

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 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  As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.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  As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
• Class II: Risk 04/30/2024
  One lot of product has dilators that are too short and will not extend outside the introducer sheath.

View all recalls by St. Jude Medical →