St Jude Medical medical device reports that give this manufacturer
- Name type
- Device manufacturer, as written on reports
What a report is
A report is not proof that the device was the cause of the event.
FDA says:
Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports on file
From July 1992 to August 2026, FDA received 61,640 medical device reports that give St Jude Medical as the manufacturer. A manufacturer name is as written on the report, so a subsidiary or a different spelling can be a separate name.
FDA received 65 reports in the 12 months to September 2026 and 1,608 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Of the 3,444,740 device reports that FDA received in the 12 months to September 2026, 65 (under 0.1%) give St Jude Medical as the manufacturer. Voluntary reports were 12.6% of the reports that name this manufacturer and 0.9% of all device reports.
The number of people who use the product is not in the data. A count is not a rate.
Why manufacturers report
FDA says:
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of . The site read the page on .
Data version
openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.
Brand names
The table has the 115 brand pages with 5 or more reports that give this manufacturer. 125 brand pages have a report in all. The rows are in order of name. A brand page with fewer reports is not in the table.
FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Brand name | Product code | Reports | Reports, 12 months to September 2026 |
|---|---|---|---|
| 3 Lesion Nt1100 Pain Management Rf Generator | Generator, lesion, radiofrequency | 41 | 0 |
| 4 Lesion NT2000 Pain Management RF Generator | Generator, lesion, radiofrequency | 244 | 3 |
| 6f Angio-Seal Evolution | Device, hemostasis, vascular | 198 | 0 |
| 6f Angio-Seal Vascular Closure Device | Device, hemostasis, vascular | 7 | 0 |
| 6f Angio-Seal Vascular Closure Device Sts | Device, hemostasis, vascular | 66 | 0 |
| 6f Angio-Seal Vascular Closure Device Sts Plus | Device, hemostasis, vascular | 249 | 0 |
| 6f Angio-Seal Vascular Closure Device Vip | Device, hemostasis, vascular | 589 | 0 |
| 8f Angio-Seal Vascular Closure Device Sts Plus | Device, hemostasis, vascular | 162 | 0 |
| Advisor HD Grid Mapping Catheter, Sensor Enabled | Catheter, electrode recording, or probe, electrode recording | 405 | 27 |
| Agilis NxT Steerable Introducer Dual-Reach 61 cm Sheath, Small Curl Dual-Reach | Introducer, catheter | 227 | 51 |
| Agilis Nxt Steerable Introducer Dual-Reach 71 Cm Sheath Large Curl 8 5f | Introducer, catheter | 34 | 17 |
| Agilis NxT Steerable Introducer Dual-Reach 71 cm Sheath, Medium Curl, 13F | Introducer, catheter | 22 | 389 |
| Agilis NxT Steerable Introducer Dual-Reach 71 cm Sheath, Medium Curl, 8.5 F | Introducer, catheter | 136 | 38 |
| Agilis NxT Steerable Introducer Dual-Reach 71 cm Sheath, Small Curl, 8.5F | Introducer, catheter | 49 | 18 |
| Ampere RF Ablation Generator | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 61 | 14 |
| Angio-Seal | Device, hemostasis, vascular | 42 | 824 |
| Angio-Seal Device | Device, hemostasis, vascular | 197 | 0 |
| Angio-Seal Vip Vascular Closure Device | Device, hemostasis, vascular | 6 | 0 |
| Assurity Mri | Implantable pulse generator, pacemaker (non-crt) | 129 | 1,954 |
| Atrial Lead | Permanent pacemaker electrode | 70 | 13 |
| Braided Swartz Introducer, SL0. 8F, 63cm | Introducer, catheter | 154 | 26 |
| Cardiomems Patient Electronic System | System, hemodynamic, implantable | 2,298 | 706 |
| CARDIOMEMS Power Supply | System, hemodynamic, implantable | 258 | 340 |
| Confirm | Recorder, event, implantable cardiac, (without arrhythmia detection) | 650 | 29 |
| Defibrillator Automatic Implantable Cardioverter With Cardiac Resynchronizatio | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 409 | 49 |
| Drug Eluting Permanent Left Ventricular Lv Pacemaker Electrode | Drug eluting permanent left ventricular (lv) pacemaker electrode | 461 | 74 |
| Drug Eluting Permanent Right Ventricular Rv Or Right Atrial Ra Pacemaker Ele | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 1,570 | 382 |
| Durata | Permanent defibrillator electrodes | 11 | 11 |
| Durata Sts Optim Active Fixation | Implantable cardioverter defibrillator (non-crt) | 434 | 292 |
| Durata Sts Optim Active Fixation Df-4 Connector | Permanent defibrillator electrodes | 1,494 | 1,705 |
| Durata Sts Optim Passive Fixation Df-4 Connector | Permanent defibrillator electrodes | 45 | 34 |
| Eon Mini | Stimulator, spinal-cord, totally implanted for pain relief | 6 | 0 |
| Epic Stented Porcine Heart Valve W/Flexfit System | Heart-valve, non-allograft tissue | 42 | 0 |
| Fast-Cath Hemostasis Introducer | Introducer, catheter | 280 | 12 |
| Fast-Cath Transseptal Guiding Introducer Swartz Sl Transseptal Series 63 Cm Le | Introducer, catheter | 101 | 7 |
| Fast-Cath Transseptal Guiding Introducer Swartz SL Transseptal Series, SL1 8. | Introducer, catheter | 432 | 24 |
| Fast-Cath Trio Hemostasis Introducer Cath-Lock Locking Hub 12 Cm Sheath 14 | Introducer, catheter | 220 | 0 |
| Flexability Ablation Catheter Sensor Enabled | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 73 | 9 |
| Fortify Assura Vr | Implantable cardioverter defibrillator (non-crt) | 25 | 0 |
| Fortify Assura Vr Icd Ide Us | Pulse generator, permanent, implantable | 221 | 0 |
| Fortify Assura VR ICD, US | Implantable cardioverter defibrillator (non-crt) | 742 | 193 |
| Fortify St Vr U1 6 Sj4 Id | Implantable cardioverter defibrillator (non-crt) | 25 | 0 |
| Fortify Vr U1 6 Df1 Id | Implantable cardioverter defibrillator (non-crt) | 84 | 0 |
| Fortify Vr U1 6 Df1 Us | Pulse generator, permanent, implantable | 173 | 9 |
| Fortify Vr U1 6 Sj4 Id | Implantable cardioverter defibrillator (non-crt) | 306 | 0 |
| Fortify Vr U1 6 Sj4 Us | Pulse generator, permanent, implantable | 405 | 8 |
| HF Sensor Delivery System | System, hemodynamic, implantable | 2,908 | 718 |
| Implantable Cardioverter Defibrillator (non-CRT) | Implantable cardioverter defibrillator (non-crt) | 868 | 183 |
| Implantable Pacemaker Pulse-Generator | Implantable pacemaker pulse-generator | 62 | 6 |
| Inquiry Steerable Diagnostic Catheter | Catheter, electrode recording, or probe, electrode recording | 92 | 7 |
| Intra-Aortic Balloon Catheter | System, balloon, intra-aortic and control | 5 | 0 |
| Isoflex Optim Lead | Permanent defibrillator electrodes | 382 | 409 |
| Isoflex S | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 25 | 0 |
| Lead | Permanent pacemaker electrode | 166 | 108 |
| Lv Lead | Drug eluting permanent left ventricular (lv) pacemaker electrode | 45 | 33 |
| Merlin Net / Hf Portal | System, hemodynamic, implantable | 102 | 34 |
| Merlin@home, RF telemetry basic | Transmitters and receivers, physiological signal, radiofrequency | 129 | 42 |
| Optisense Lead | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 82 | 136 |
| Optisure Active Fixation Df-4 Connector | Permanent defibrillator electrodes | 86 | 611 |
| Permanent Defibrillator Electrodes | Permanent defibrillator electrodes | 531 | 220 |
| Permanent Pacemaker Electrode | Permanent pacemaker electrode | 759 | 309 |
| Power cord 110V | System, hemodynamic, implantable | 49 | 89 |
| PressureWire | Transducer, pressure, catheter tip | 14 | 82 |
| Pulse Generator Permanent Implantable | Pulse generator, permanent, implantable | 532 | 21 |
| Quadra Assura Crt-D Quad Rf Hv | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 2,349 | 12 |
| Quadra Assura Ddqp+ | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,463 | 0 |
| Quadra Assura ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 700 | 69 |
| Quadra Assura MP ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,626 | 489 |
| Quartet | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 608 | 822 |
| Quartet Lead Small-S, 86 cm | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 40 | 147 |
| Quickflex Micro Lv Lead | Drug eluting permanent left ventricular (lv) pacemaker electrode | 65 | 104 |
| RA Lead | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 131 | 62 |
| Riata | Implantable cardioverter defibrillator (non-crt) | 76 | 7 |
| Riata Active Fixation | Permanent defibrillator electrodes | 58 | 86 |
| Riata Active Fixation Lead | Implantable cardioverter defibrillator (non-crt) | 5 | 0 |
| Riata Active-Fixation Lead | Implantable cardioverter defibrillator (non-crt) | 15 | 0 |
| Riata Passive Fixation | Permanent defibrillator electrodes | 207 | 31 |
| RV Lead | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 180 | 145 |
| Sjm Masters Series Mechanical Heart Valve | Heart-valve, mechanical | 9 | 0 |
| Sjm Mechanical Heart Valve | Heart-valve, mechanical | 8 | 0 |
| Sjm Regent Heart Valve W/Flex Cuff | Heart-valve, mechanical | 5 | 0 |
| Sjm Trifecta Valve | Heart-valve, non-allograft tissue | 110 | 0 |
| Spl Lead System | Permanent pacemaker electrode | 5 | 0 |
| Standard Cuff | Heart-valve, mechanical | 236 | 0 |
| Swartz Braided Transseptal Guiding Introducer, SL0, 63 cm Length, 8.5 F | Introducer, catheter | 584 | 201 |
| Swartz Braided Transseptal Guiding Introducer, SL0, 63 cm Length, 8F | Introducer, catheter | 73 | 25 |
| Swartz Braided Transseptal Guiding Introducer, SL1, 63 cm Length, 8.5F | Introducer, catheter | 172 | 65 |
| Swartz Braided Transseptal Introducer, SL0, 8.5 F | Introducer, catheter | 296 | 93 |
| Swartz Introducer, Unknown | Introducer, catheter | 60 | 18 |
| Symmetry Bypass System | Clip, implantable | 192 | 0 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 250 | 27 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve D-F | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 723 | 35 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve F-J | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 128 | 6 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled UniD Curve D | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 150 | 10 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled UniD Curve F | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 58 | 4 |
| Tacticath Quartz Contact Force Ablation Catheter 65mm | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 10 | 0 |
| Tacticath Quartz Contact Force Ablation Catheter 75mm | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 55 | 0 |
| TactiFlex Ablation Catheter, Sensor Enabled | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 266 | 151 |
| Tactisys Quartz Ablation System | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 98 | 14 |
| Tendril | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 53 | 9 |
| Tendril Mri | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 73 | 401 |
| Tendril Sdx | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 93 | 3 |
| Tendril St | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 365 | 523 |
| Tendril Sts | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 1,185 | 4,145 |
| Transseptal Needle, BRK Series | Trocar | 40 | 32 |
| Trifecta Stented Tissue Valve | Heart-valve, non-allograft tissue | 57 | 0 |
| Unify Assura CRT-D RF HV | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,340 | 180 |
| Unify Assura Ddqp+ | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 154 | 0 |
| Unify Assura ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,805 | 122 |
| Unify Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 3,069 | 10 |
| Unify Quadra Crt-D Ous Model Df1comp | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 46 | 0 |
| Unify Quadra Crt-D Us Model Df1comp | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 67 | 1 |
| Unify Quadra Crt-D Us Model Df4comp | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 633 | 4 |
| Unify Quadra CRT-D, OUS model, DF4comp | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 496 | 3 |
| ViewFlex Xtra ICE Catheter | Catheter, ultrasound, intravascular | 279 | 63 |
Device types
The table has the 35 device types with 5 or more reports that give this manufacturer. The rows are in order of name.
FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Reports by month
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Event type
| Event type | Reports | Share | Share as a bar |
|---|---|---|---|
| Death | 1,080 | 1.8% | |
| Injury | 36,723 | 59.6% | |
| Malfunction | 23,555 | 38.2% | |
| Other | 181 | 0.3% | |
| Not given | 101 | 0.2% |
The event type is the classification that the reporter gave. FDA does not verify it.
Official pages
- Medical Device Reporting (MDR): How to Report Medical Device ProblemsThe FDA page that tells how to report a problem with a medical device.
- MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
- Manufacturer and User Facility Device Experience (MAUDE) DatabaseThe search page of FDA for the device reports.
The site checked these addresses on . The links open in a new tab.
Cite this page
Reported Reactions. St Jude Medical: medical device reports that give this manufacturer. https://reportedreactions.com/manufacturer/st-jude-medical/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.
The site removes company suffixes (Inc., LLC, GmbH and similar) before it counts a manufacturer name. A name that reads as a person and not as an organisation is not published. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
Does a large count say something about the manufacturer?
Not by itself. FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
What event types do the reports record?
Death (1,080), injury (36,723), malfunction (23,555) and other (181). The event type is the classification that the reporter gave. FDA does not verify it.
Why can one company have more than one page?
The manufacturer field is free text on the report. This page counts the 61,640 reports with the name St Jude Medical after the site removes company suffixes. A subsidiary, a plant or a different spelling is a separate name.