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St. Jude Medical FDA Recalls
13 recalls on file across devices, 0 of them Class I and 13 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend WebClass IIFeb 3, 2025Due to issues associated with data migration of patient info |
| Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" HClass IINov 6, 2024Due to a data migration from on-premises server to the cloud |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.neClass IIOct 5, 2024As a result of a cloud data migration of Patient and Hospita |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.nClass IIOct 5, 2024As a result of a cloud data migration of Patient and Hospita |
| St. Jude Medical Agilis NxT Steerable Introducer, REF 408309Class IIApr 30, 2024One lot of product has dilators that are too short and will |
| CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmoClass IIOct 4, 2023Potential for damaged and frayed power connector plug with r |
| CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary Class IIFeb 7, 2023Radiated Radiofrequency (RF) emissions of the CardioMEMS Pa |
| CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary Class IIFeb 7, 2023Radiated Radiofrequency (RF) emissions of the CardioMEMS Pa |
| CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artClass IIFeb 7, 2023Select CardioMEMS PA Sensors (Model CM2000) operate outside |
| CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonaryClass IIFeb 7, 2023Radiated Radiofrequency (RF) emissions of the CardioMEMS Pa |
| CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artClass IIFeb 7, 2023Select CardioMEMS PA Sensors (Model CM2000) operate outside |
| CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artClass IIFeb 7, 2023Select CardioMEMS PA Sensors (Model CM2000) operate outside |
| CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary Class IIFeb 7, 2023Radiated Radiofrequency (RF) emissions of the CardioMEMS Pa |