St. Jude Medical: Device Recall
Recall #Z-0988-2025 · 10/05/2024
Recall Details
- Recall Number
- Z-0988-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- St. Jude Medical
- Status
- Ongoing
- Date Initiated
- 10/05/2024
- Location
- Atlanta, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 605 units
Reason for Recall
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Product Description
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and the countries of Australia, and Canada.
Other Recalls by St. Jude Medical
- Class II: Risk 02/03/2025
- Class II: Risk 11/06/2024
- Class II: Risk 10/05/2024
- Class II: Risk 04/30/2024