PlainRecalls

St. Jude Medical

15 recalls on record · Latest: Apr 2, 2025

FDA Devices Moderate Apr 2, 2025

CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -M…

FDA Devices Moderate Jan 29, 2025

Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) …

FDA Devices Moderate Jul 24, 2024

St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

FDA Devices Moderate Nov 15, 2023

CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and hear…

FDA Devices Moderate Mar 15, 2023

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data use…

FDA Devices Moderate Mar 15, 2023

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data use…

FDA Devices Moderate Mar 15, 2023

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data use…

FDA Devices Moderate Mar 15, 2023

CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data…

FDA Devices Moderate Mar 15, 2023

CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data …

FDA Devices Moderate Mar 15, 2023

CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data …

FDA Devices Moderate Mar 25, 2015

TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization…

FDA Devices Moderate Nov 12, 2014

St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353

FDA Devices Moderate Aug 7, 2013

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 including u…

FDA Devices Moderate Jul 31, 2013

Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuati…

FDA Devices Moderate Jul 24, 2013

Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intra…