Company ยท US
St Jude Medical
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2018. Name variants (Inc, Corp, punctuation) are merged.
128510(k) clearances (0 in 12 months)
97recalls (0 in 12 months)
16recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DYB | Introducer, Catheter | 29 |
| DQK | Computer, Diagnostic, Programmable | 24 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 20 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 15 |
| DQY | Catheter, Percutaneous | 14 |
| MOM | System, Hemodynamic, Implantable | 12 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 11 |
| KRH | Ring, Annuloplasty | 10 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | 8 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 8 |
| DQX | Wire, Guide, Catheter | 7 |
| DXY | Implantable Pacemaker Pulse-Generator | 6 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | 6 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 5 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 3 |
| LPB | Cardiac Ablation Percutaneous Catheter | 3 |
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | 3 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | 3 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 20, 2018 | K181382 | GuardianTM Burr Hole Cover System St Jude Medical | GXR |
| Apr 23, 2018 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 St Jude Medical | DQK |
| Apr 23, 2018 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled St. Jude Medical, Inc. | MTD |
| Nov 2, 2017 | K173232 | myMerlin(TM) Mobile Application Model APP1001 St Jude Medical | MXC |
| Sep 29, 2017 | K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System St. Jude Medical, Inc. | MXC |
| Dec 13, 2016 | K162643 | MediGuide Technology System St Jude Medical | DQK |
| Dec 13, 2016 | 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 St Jude Medical | DRF |
| Dec 13, 2016 | K160218 | AutoMark Module St Jude Medical | DQK |
| Dec 13, 2016 | K160210 | EnSite Precision Cardiac Mapping System v2.0 St Jude Medical | DQK |
| Nov 22, 2016 | K161873 | Pacel Flow Directed Pacing Catheter St Jude Medical | LDF |
| Oct 21, 2016 | K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 St Jude Medical | DQK |
| Oct 7, 2016 | K160186 | EnSite Velocity Surface Electrode Kit St Jude Medical | DQK |
| Aug 15, 2016 | K161171 | PressureWire X Guidewire St. Jude Medical, Inc. | DXO |
| Jun 9, 2016 | K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover St Jude Medical | GXR |
| May 19, 2016 | K161102 | Nanostim Introducer Kit St. Jude Medical, Inc. | DYB |
| Apr 14, 2016 | K160716 | The Nanostim Introducer Kit St. Jude Medical, Inc. | DYB |
| Oct 22, 2015 | K152784 | Pacel Bipolar Pacing Catheters St Jude Medical | LDF |
| Oct 22, 2015 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus St Jude Medical | DQK |
| Jul 15, 2015 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Re St Jude Medical | DRF |
| Apr 1, 2015 | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter St Jude Medical | DRF |
| Dec 18, 2014 | K142239 | CPS Direct MediGuide Enabled outer catheter St Jude Medical | DQY |
| Dec 18, 2014 | K142235 | CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter St Jude Medical | DQY |
| Dec 17, 2014 | K140793 | NANOSTIM INTRODUCER KIT St. Jude Medical, Inc. | DYB |
| Nov 13, 2014 | K142254 | CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector St Jude Medical | DQX |
| Jun 6, 2014 | K141050 | ENSITE VELOCITY SYSTEM St Jude Medical | DQK |
| May 28, 2014 | K133481 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) St. Jude Medical, Inc. | MXC |
| May 2, 2014 | K140272 | SWIFT-LOCK ANCHOR St Jude Medical | GZB |
| Mar 11, 2014 | K140327 | ULTIMUM EV HEMOSTASIS INTRODUCER St Jude Medical | DYB |
| Jan 31, 2014 | K131592 | ENLIGHTN RENAL GUIDE CATHETER St. Jude Medical, Inc. | DQY |
| Sep 9, 2013 | K132073 | EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE St Jude Medical | DQK |
| Aug 29, 2013 | K130727 | ENSITE VELOCITY SYSTEM St Jude Medical | DQK |
| Aug 15, 2013 | K131063 | AMPLATZER TORQ VUE LP DELIVERY SYSTEM St Jude Medical | DQY |
| Jun 18, 2013 | K130545 | MULTI LEAD TRIAL CABLE St Jude Medical | GZB |
| May 3, 2013 | K130594 | ENSITE VELOCITY SYSTEM St Jude Medical | DQK |
| Mar 20, 2013 | K130257 | CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER St Jude Medical | DQY |
| Mar 20, 2013 | K130252 | CPS AIM UNIVERSAL SLITTABLE INNER CATHETER St Jude Medical | DQY |
| Feb 7, 2013 | K122587 | BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 St Jude Medical | DRC |
| Nov 28, 2012 | K122161 | SJM CONFIRM St Jude Medical | MXC |
| Jun 7, 2012 | K121381 | VIEWFLEX XTRA ICE CATHETER St Jude Medical | IYO |
| May 3, 2012 | K121006 | ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER St Jude Medical | MTD |
| Apr 20, 2012 | K113611 | RAPID PROGRAMMER St Jude Medical | GZB |
| Mar 19, 2012 | K120544 | RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN St Jude Medical | DRF |
| Mar 2, 2012 | K113584 | PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER St Jude Medical | DXO |
| Jan 18, 2012 | K113773 | ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL St Jude Medical | KRA |
| Nov 9, 2011 | K112688 | ENSITE VELOCITY SYSTEM V.3.0 St Jude Medical | DQK |
| Jun 24, 2011 | K110609 | EPIDUCER LEAD DELIVERY SYSTEM St Jude Medical | LHG |
| Jun 9, 2011 | K111092 | ENGAGE/ENGAGE TR INTRODUCERS St Jude Medical | DYB |
| May 10, 2011 | K110450 | AGILIS NXT STEERABLE INTRODUCER St Jude Medical | DYB |
| May 5, 2011 | K110549 | ENSITE VELOCITY SYSTEM St Jude Medical | DQK |
| Apr 8, 2011 | K103083 | AGILIS ES STEERABLE INTRODUCER St Jude Medical | DYB |
Newest 50 of 128.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2025 | St. Jude Medical 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 Open, Classified |
MOM | None listed |
| Jan 17, 2025 | St. Jude Medical 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 Open, Classified |
MOM | None listed |
| Jan 17, 2025 | St. Jude Medical 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 Open, Classified |
MOM | None listed |
| Jan 17, 2025 | St. Jude Medical 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 Open, Classified |
MOM | None listed |
| Jul 12, 2024 | St. Jude Medical St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 Open, Classified |
DYB | K061363 |
| Nov 3, 2023 | St. Jude Medical CardioMEMS Patient Electronic System (PES), Model Number CM1100.
Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate. Open, Classified |
MOM | None listed |
| Mar 6, 2023 | St. Jude Medical 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 failur Open, Classified |
MOM | None listed |
| Mar 6, 2023 | St. Jude Medical 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 failur Open, Classified |
MOM | None listed |
| Mar 6, 2023 | St. Jude Medical 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 failur Open, Classified |
MOM | None listed |
| Mar 3, 2023 | St. Jude Medical CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fa Open, Classified |
MOM | None listed |
| Mar 3, 2023 | St. Jude Medical CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fai Open, Classified |
MOM | None listed |
| Mar 3, 2023 | St. Jude Medical CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fai Open, Classified |
MOM | None listed |
| Mar 3, 2023 | St. Jude Medical 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 fai Open, Classified |
MOM | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615 Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585 Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE DR, REF: CD2377-36QC
Implantable cardioverter defibrillators (ICDs) Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738 Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE VR, REF: CD1377-36QC
Implantable cardioverter defibrillators (ICDs) Terminated |
LWS | None listed |
| Aug 2, 2019 | St Jude Medical Inc. ELLIPSE VR, REF: CD1377-36C
Implantable cardioverter defibrillators (ICDs) Terminated |
LWS | None listed |
| Oct 11, 2018 | St. Jude Medical, Inc. St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY
CE 0086 0123
St. Jude Medical
Plano, TX
St. Jude Medical InfinityTM DBS System 8CH Directional Le Terminated |
MHY | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Merlin PCS Programmer Software: 3330
The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the p Terminated |
MXC | K163407 |
| Apr 16, 2018 | St Jude Medical Inc. St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500
The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained Terminated |
MXC | K163407 |
| Apr 16, 2018 | St Jude Medical Inc. Merlin PCS programmer (Model # 3650), Software (Model # 3330) Terminated |
OSR | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Unify Quadra, Sterile EO, Model #/ Part #:
CD3249-40/100036404, 100038435,
CD3249-40Q/100036407, 100038436,
CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563,
CD3251-40Q/1 Terminated |
NIK | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Unify Assura, Sterile EO, Model #/ Part #:
CD3257-40/100042333, 100059944;
CD3257-40Q/100042334, 100059936;
CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828;
CD3261-40Q/1 Terminated |
NIK | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Unify, Sterile EO, Model #/ Part #:
CD3231-40/100029240, 100030104, 100041904;
CD3231-40Q/100029281, 100030124, 100041905;
CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897 Terminated |
NIK | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Quadra Assura MP, Sterile EO, Model #/ Part #:
CD3269-40/100043177;
CD3269-40Q/100043178;
CD3271-40/100043130;
CD3271-40Q/100043191;
CD3369-40C/100080339, 100080478;
CD3369-40Q/100080439, 100080 Terminated |
NIK | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Quadra Assura, Sterile EO, Model #/ Part #:
CD3265-40/100042335, 100059846;
CD3265-40Q/100042336, 100059847;
CD3267-40/100042956, 100043569, 100059961, 100078810;
CD3267-40Q/100043132, 100043539, 1 Terminated |
NIK | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Promote Quadra, Sterile EO, Model # / Part #:
CD3221-36/100025054, 60019195;
CD3223-36P/100013763;
CD3239-40/100029115, 100029254, 100037181;
CD3239-40Q/100029116, 100029244, 100037115 Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Promote, Sterile EO, Model #/ Part #:
3207-30/60010740-207, 60010740-407;
3207-36/60010743-207, 60010743-407;
3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707;
CD3211-36/100006984,10 Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Fortify Assura, Sterile EO, Model #/ Part #:
CD1257-40/100042322, 100059623;
CD1257-40Q/100042341, 100059535;
CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567;
CD1259-40Q/100041931, Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Fortify, Sterile EO, Model #/ Part #:
CD1231-40/100029238,100030095, 100041981;
CD1231-40Q/100029229, 100030087, 100041982;
CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017 Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Ellipse, Sterile EO, Model #/ Part #:
CD1275-36/100116115;
CD1275-36Q/100116116;
CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636;
CD1277-36Q/100048374, 100048394, 100060198, 10009849 Terminated |
LWS | None listed |
| Apr 16, 2018 | St Jude Medical Inc. Current, Sterile EO, Model #/ Part #:
1207-30/50020236-001, 60010739-207, 60010739-407;
1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707;
2207-30/ 50020238-001, 60010738- Terminated |
LWS | None listed |
| Mar 23, 2018 | St. Jude Medical, Inc. Proclaim DRG Implantable Pulse Generator, Model Number 3664 Terminated |
PMP | None listed |
| Oct 10, 2017 | St Jude Medical Inc. Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Terminated |
NIK | None listed |
| Oct 10, 2017 | St Jude Medical Inc. Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify A Terminated |
LWS | None listed |
| Sep 12, 2017 | St. Jude Medical, Inc. Proclaim DRG Implantable Pulse Generator Model 3664 Terminated |
LGW | None listed |
| Sep 12, 2017 | St. Jude Medical, Inc. Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663 Terminated |
MHY | None listed |
| Sep 12, 2017 | St. Jude Medical, Inc. Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667 Terminated |
LGW | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply Terminated |
NKE | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM 1260 ASSURITY +
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that pr Terminated |
DXY | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power s Terminated |
DXY | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply an Terminated |
LWP | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that Terminated |
NKE | None listed |
| Aug 28, 2017 | St Jude Medical Inc. Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W.
The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care Sy Terminated |
OSR | None listed |
| Aug 28, 2017 | St Jude Medical Inc. Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1
The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate progra Terminated |
NIK | None listed |
| Aug 28, 2017 | St Jude Medical Inc. Assurity MRI Model Numbers: PM1272, PM2272
Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: S Terminated |
DXY | None listed |
| Aug 28, 2017 | St Jude Medical Inc. Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224
Implantation of a single Terminated |
DXY | None listed |
| Aug 28, 2017 | St Jude Medical Inc. Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244
Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CR Terminated |
NKE | None listed |
Newest 50 of 97.