St. Jude Medical: Device Recall
Recall #Z-1427-2025 · 02/03/2025
Recall Details
- Recall Number
- Z-1427-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- St. Jude Medical
- Status
- Ongoing
- Date Initiated
- 02/03/2025
- Location
- Atlanta, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 193 devices
Reason for Recall
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.
Product Description
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 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. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA WI, and WV.
Other Recalls by St. Jude Medical
- Class II: Risk 11/06/2024
- Class II: Risk 10/05/2024
- Class II: Risk 10/05/2024
- Class II: Risk 04/30/2024