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St. Jude Medical

FDA Regulatory Profile

Summary

Total Recalls
32
510(k) Clearances
23
Inspections
16
Compliance Actions
3

Known Names

st. jude medical, st jude medical, st. jude medical systems, st. jude medical sweden

Recent Recalls

NumberClassProductDate
Z-1427-2025Class IICardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CaFebruary 3, 2025
Z-0987-2025Class IIMerlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaceNovember 6, 2024
Z-0989-2025Class IICARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) October 5, 2024
Z-0988-2025Class IICARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) ROctober 5, 2024
Z-2348-2024Class IISt. Jude Medical Agilis NxT Steerable Introducer, REF 408309April 30, 2024
Z-0218-2024Class IICardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring October 4, 2023
Z-1218-2023Class IICardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF SystemFebruary 7, 2023
Z-1219-2023Class IICardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF SystemFebruary 7, 2023
Z-1220-2023Class IICardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF SystemFebruary 7, 2023
Z-1221-2023Class IICardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF SysteFebruary 7, 2023
Z-1224-2023Class IICardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System prFebruary 7, 2023
Z-1223-2023Class IICardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System prFebruary 7, 2023
Z-1225-2023Class IICardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System prFebruary 7, 2023
Z-0593-2019Class IISt. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLOctober 11, 2018
Z-1170-2018Class IIProclaim DRG Implantable Pulse Generator, Model Number 3664March 9, 2018
Z-0023-2018Class IIInfinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661,September 12, 2017
Z-0024-2018Class IIProclaim DRG Implantable Pulse Generator Model 3664September 12, 2017
Z-0022-2018Class IIProclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator ModelsSeptember 12, 2017
Z-2691-2017Class IIProclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The June 2, 2017
Z-2692-2017Class IIProclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The June 2, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K172393Advisor HD Grid Mapping Catheter, Sensor EnabledApril 23, 2018
K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSeptember 29, 2017
K161171PressureWire X GuidewireAugust 15, 2016
K161102Nanostim Introducer KitMay 19, 2016
K160716The Nanostim Introducer KitApril 14, 2016
K140793NANOSTIM INTRODUCER KITDecember 17, 2014
K133481SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)May 28, 2014
K131592ENLIGHTN RENAL GUIDE CATHETERJanuary 31, 2014
K0737006F PROXIS SYSTEMOctober 2, 2008
K042734SJM RIGID SADDLE RING MODEL RSAR-(SIZE)December 17, 2004
K022363SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)September 19, 2002
K014161SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)January 15, 2002
K014037SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)January 4, 2002
K001367FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXXMay 31, 2000
K001346ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XXMay 24, 2000
K000119SJM TAILOR ANNULOPLASTY RING, MODEL TARNFebruary 17, 2000
K961246SJM SEGUIN ANNULOPLASTY RING MODEL SAR-MFebruary 14, 1997
K935184REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATINGFebruary 10, 1995
K933014LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PISeptember 28, 1994
K921550LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CPMay 21, 1992