Skip to main content
All Recalls

Every St. Jude Medical Recall

Sorted by most recent. Click any recall for full details.

15 recalls
High RiskFDA
St. Jude Medical
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Mode...
Cardiac Devices·193 affected·Feb 3, 2025
High RiskFDA
St. Jude Medical
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System mo...
Cardiac Devices·25 affected·Nov 6, 2024
High RiskFDA
St. Jude Medical
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Medical Devices·129 affected·Apr 30, 2024
High RiskFDA
St. Jude Medical
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery press...
Cardiac Devices·36,153 affected·Oct 4, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·317 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·36,875 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·1,905 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemo...
Cardiac Devices·1,905 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemod...
Cardiac Devices·200 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemod...
Cardiac Devices·3,177 affected·Feb 7, 2023
High RiskFDA
St Jude Medical
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows v...
Cardiac Devices·89 affected·Nov 25, 2014
High RiskFDA
St Jude Medical
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Surgical Devices·26 affected·Oct 14, 2014
High RiskFDA
St. Jude Medical
Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is ...
Medical Devices·75,663 affected·Nov 30, 2012
High RiskFDA
St. Jude Medical
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs...
Medical Devices·34,617 affected·Jul 26, 2012
CriticalFDA
St. Jude Medical
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of c...
Medical Devices·70,638 affected·Jul 26, 2012