St Jude Medical
St Jude Medical holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2018, with 22 FDA device recalls on record.
Top product codes for St Jude Medical
FDA recalls by St Jude Medical
10 most recent of 22- Z-1427-2025 — CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
- Z-0987-2025 — Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
- Z-0988-2025 — 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
- Z-0989-2025 — 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
- Z-2348-2024 — St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
- Z-0218-2024 — CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
- Z-1225-2023 — CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
- Z-1223-2023 — CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
- Z-1224-2023 — CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
- Z-1218-2023 — CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by St Jude Medical
1–100 of 105- K181382 — GuardianTM Burr Hole Cover System
- K172396 — EnSite Velocity Cardiac Mapping System v5.2
- K173232 — myMerlin(TM) Mobile Application Model APP1001
- K160210 — EnSite Precision Cardiac Mapping System v2.0
- K160218 — AutoMark Module
- K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
- K162643 — MediGuide Technology System
- K161873 — Pacel Flow Directed Pacing Catheter
- K160187 — Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
- K160186 — EnSite Velocity Surface Electrode Kit
- K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
- K151911 — WorkMate Claris System, WorkMate Claris System Display Plus
- K152784 — Pacel Bipolar Pacing Catheters
- K151622 — St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter
- K150631 — St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter
- K142235 — CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
- K142239 — CPS Direct MediGuide Enabled outer catheter
- K142254 — CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector
- K141050 — ENSITE VELOCITY SYSTEM
- K140272 — SWIFT-LOCK ANCHOR
- K140327 — ULTIMUM EV HEMOSTASIS INTRODUCER
- K132073 — EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
- K130727 — ENSITE VELOCITY SYSTEM
- K131063 — AMPLATZER TORQ VUE LP DELIVERY SYSTEM
- K130545 — MULTI LEAD TRIAL CABLE
- K130594 — ENSITE VELOCITY SYSTEM
- K130252 — CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
- K130257 — CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
- K122587 — BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
- K122161 — SJM CONFIRM
- K121381 — VIEWFLEX XTRA ICE CATHETER
- K121006 — ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
- K113611 — RAPID PROGRAMMER
- K120544 — RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
- K113584 — PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
- K113773 — ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
- K112688 — ENSITE VELOCITY SYSTEM V.3.0
- K110609 — EPIDUCER LEAD DELIVERY SYSTEM
- K111092 — ENGAGE/ENGAGE TR INTRODUCERS
- K110450 — AGILIS NXT STEERABLE INTRODUCER
- K110549 — ENSITE VELOCITY SYSTEM
- K103083 — AGILIS ES STEERABLE INTRODUCER
- K110085 — VANTAGE VIEW SYSTEM
- K102721 — LIVEWIRE ELECTOPHYSIOLOGY CATHETER
- K101955 — ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
- K101697 — ENSITE VERISMO SEGMENTATION TOOL V.2.0
- K101968 — SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
- K101883 — 6F ENGAGE/ENGAGE TR INTRODUCER
- K101623 — INQUIRY AFOCUSII DIAGNOSTIC CATHETER
- K101328 — ENSITE VELOCITY SYSTEM
- K101667 — ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)
- K101419 — ENSITE VELOCITY SYSTEM, MODEL EE3000
- K101239 — VIEWFLEX PLUS ICE CATHETER
- K100710 — ROLL-X GUIDEWIRE
- K093942 — ENSITE VELOCITY SYSTEM V1.3
- K093583 — EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
- K093130 — ENGAGE TR INTRODUCER
- K092876 — SJM ATTUNE ANNULOPLASTY RING
- K092810 — EP-WORKMATE SYSTEM, VERSION 4.2
- K092575 — ENGAGE/ENGAGE TR
- K092310 — SEGUIN ANNULOPLASTY RING
- K083328 — ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
- K081803 — ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
- K091137 — ULTIMUM/ENGAGE/ENGAGE TR
- K090163 — STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
- K083835 — ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
- K080179 — REFLEXION HD HIGH-DENSITY MAPPING CATHETER
- K083402 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
- K082932 — CPS AIM SL SLITTABLE INNER CATHETER
- K081645 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
- K083083 — AGILIS NXT STEERABLE INTRODUCER
- K082279 — EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
- K082467 — ENSITE FUSION DYNAMIC REGISTRATION TOOL
- K082304 — ROLL-X GUIDEWIRE
- K081365 — SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
- K080292 — EPICOR ABLATION SYSTEM
- K073563 — MODIFICATION TO PROXIS SYSTEM
- K071818 — ENSITE FUSION DYNAMIC REGISTRATION TOOL
- K072278 — BRK TRANSSEPTAL NEEDLE
- K072012 — REFLEXION SPIRAL VARIABLE RADIUS CATHETER
- K070417 — ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
- K063638 — MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
- K070902 — MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
- K070166 — STRADA CAROTID GUIDING SHEATH
- K062251 — REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
- K060651 — PROXIS SYSTEM, MODEL EPS101
- K061015 — FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
- K061843 — VENTURE WIRE CONTROL CATHETER, MODEL WCC
- K061710 — CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS
- K061363 — AGILIS NXT STEERABLE INTRODUCER
- K053217 — CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
- K053277 — CPS DIRECT SL OUTER CATHETER
- K052575 — LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
- K052644 — SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
- K051840 — ENSITE VERISMO SOFTWARE
- K040165 — REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
- K031906 — APEEL CS CATHETER DELIVERY SYSTEM
- K023447 — MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
- K022380 — LIVESIRE ELECTROPHYSIOLOGY CATHETER
- K020890 — SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.