Recall Z-0989-2025— St. Jude Medical
Class II · Ongoing
Class II FDA medical device recall by St. Jude Medical, initiated 2024-10-05. FDA's recall record names no specific 510(k) clearance for this event. Product: CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 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. Reason: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings..
- Recalling firm
- St. Jude Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-05
- Firm location
- Atlanta, GA, United States
Product description
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 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
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As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Data sourced from openFDA. This site is unofficial and independent of the FDA.