St. Jude Medical
St. Jude Medical appears in FDA public data with 32 recalls, 23 510(k) clearances, 18 FDA inspections, and 3 compliance actions on record. Its most recent recall (Z-1427-2025, Class II) was initiated on February 3, 2025. Its most recent 510(k) clearance was granted on April 23, 2018.
Summary
- Total Recalls
- 32
- 510(k) Clearances
- 23
- Inspections
- 18
- Compliance Actions
- 3
Known Names
st jude medical, st. jude medical, st. jude medical systems, st. jude medical sweden
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1427-2025 | Class II | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -Ca | February 3, 2025 |
| Z-0987-2025 | Class II | Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interface | November 6, 2024 |
| Z-0989-2025 | Class II | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) | October 5, 2024 |
| Z-0988-2025 | Class II | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) R | October 5, 2024 |
| Z-2348-2024 | Class II | St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 | April 30, 2024 |
| Z-0218-2024 | Class II | CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring | October 4, 2023 |
| Z-1219-2023 | Class II | CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System | February 7, 2023 |
| Z-1221-2023 | Class II | CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF Syste | February 7, 2023 |
| Z-1220-2023 | Class II | CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System | February 7, 2023 |
| Z-1218-2023 | Class II | CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System | February 7, 2023 |
| Z-1224-2023 | Class II | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System pr | February 7, 2023 |
| Z-1223-2023 | Class II | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System pr | February 7, 2023 |
| Z-1225-2023 | Class II | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System pr | February 7, 2023 |
| Z-0593-2019 | Class II | St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONL | October 11, 2018 |
| Z-1170-2018 | Class II | Proclaim DRG Implantable Pulse Generator, Model Number 3664 | March 9, 2018 |
| Z-0024-2018 | Class II | Proclaim DRG Implantable Pulse Generator Model 3664 | September 12, 2017 |
| Z-0022-2018 | Class II | Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models | September 12, 2017 |
| Z-0023-2018 | Class II | Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, | September 12, 2017 |
| Z-2694-2017 | Class II | Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infini | June 2, 2017 |
| Z-2693-2017 | Class II | Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infi | June 2, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | April 23, 2018 |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | September 29, 2017 |
| K161171 | PressureWire X Guidewire | August 15, 2016 |
| K161102 | Nanostim Introducer Kit | May 19, 2016 |
| K160716 | The Nanostim Introducer Kit | April 14, 2016 |
| K140793 | NANOSTIM INTRODUCER KIT | December 17, 2014 |
| K133481 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) | May 28, 2014 |
| K131592 | ENLIGHTN RENAL GUIDE CATHETER | January 31, 2014 |
| K073700 | 6F PROXIS SYSTEM | October 2, 2008 |
| K042734 | SJM RIGID SADDLE RING MODEL RSAR-(SIZE) | December 17, 2004 |
| K022363 | SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) | September 19, 2002 |
| K014161 | SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) | January 15, 2002 |
| K014037 | SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) | January 4, 2002 |
| K001367 | FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX | May 31, 2000 |
| K001346 | ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX | May 24, 2000 |
| K000119 | SJM TAILOR ANNULOPLASTY RING, MODEL TARN | February 17, 2000 |
| K961246 | SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M | February 14, 1997 |
| K935184 | REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING | February 10, 1995 |
| K933014 | LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI | September 28, 1994 |
| K921550 | LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP | May 21, 1992 |