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St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.ne
Recalled January 29, 2025 · FDA recall Z-0988-2025 · St. Jude Medical
Hazard
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings. · FDA Class II
Units
605 units
Sold at
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.
Description
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.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
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
Manufacturer(s)
St. Jude Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →