Biosense Webster 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 January 2000 to September 2026, FDA received 24,752 medical device reports that give Biosense Webster 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 3,374 reports in the 12 months to September 2026 and 3,640 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, 3,374 (0.1%) give Biosense Webster as the manufacturer. Distributor reports were 0.4% of the reports that name this manufacturer and 3.6% 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 34 brand pages with 5 or more reports that give this manufacturer. 37 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 |
|---|---|---|---|
| Carto 3 System | Computer, diagnostic, programmable | 477 | 20 |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath - Medium | Introducer, catheter | 885 | 14 |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath - Small | Introducer, catheter | 701 | 5 |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath Large | Introducer, catheter | 166 | 0 |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath Medium | Introducer, catheter | 1,381 | 0 |
| Carto Vizigo 8 5f Bi-Directional Guiding Sheath Small | Introducer, catheter | 870 | 0 |
| Decanav Electrophysiology Catheter | Catheter, electrode recording, or probe, electrode recording | 130 | 0 |
| Ez Steer Nav Bi-Directional Electrophysiology Catheter | Cardiac ablation percutaneous catheter | 82 | 0 |
| Ez Steer Thermocool Nav Bi-Directional Catheter | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 6 | 0 |
| Navi-Star Thermo-Cool Electrophysiology Catheter | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 116 | 0 |
| Navistar Electrophysiology Catheter | Catheter, electrode recording, or probe, electrode recording | 51 | 0 |
| Navistar Rmt Thermocool Electrophysiology Catheter | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 58 | 0 |
| NaviStar ThermoCool | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 134 | 18 |
| OCTARAY Mapping Catheter | Catheter, intracardiac mapping, high-density array | 396 | 92 |
| Pentaray Nav | Catheter, intracardiac mapping, high-density array | 394 | 189 |
| Pentaray Nav High-Density Mapping Eco Catheter | Catheter, intracardiac mapping, high-density array | 532 | 4 |
| Preface Guiding Sheath With Multipurpose Curve | Introducer, catheter | 145 | 0 |
| QDOT Micro | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 1,181 | 371 |
| Qdot Micro Catheter | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 538 | 16 |
| Soundstar | Catheter, ultrasound, intravascular | 168 | 27 |
| Thermocool Sf Nav Bi-Directional Catheter | Cardiac ablation percutaneous catheter | 25 | 0 |
| Thermocool Sf Nav Uni-Directional Catheter | Cardiac ablation percutaneous catheter | 13 | 0 |
| Thermocool Smart Touch Bi-Directional Navigation Catheter | Cardiac ablation percutaneous catheter | 507 | 0 |
| Thermocool Smart Touch Electrophysiology Catheter | Cardiac ablation percutaneous catheter | 713 | 3 |
| Thermocool Smart Touch Sf Bi-Directional Navigation Catheter | Cardiac ablation percutaneous catheter | 4,535 | 5 |
| Thermocool Smart Touch Sf Uni-Directional Navigation Catheter | Cardiac ablation percutaneous catheter | 875 | 9 |
| ThermoCool SmartTouch | Cardiac ablation percutaneous catheter | 301 | 95 |
| Thermocool Smarttouch Bi-Directional Navigation Catheter | Cardiac ablation percutaneous catheter | 32 | 0 |
| ThermoCool SmartTouch SF | Cardiac ablation percutaneous catheter | 1,738 | 633 |
| Thermocool Smarttouch Uni-Directional Navigation Catheter | Cardiac ablation percutaneous catheter | 9 | 0 |
| Unk Navistar Thermocool | Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | 220 | 0 |
| Unk Smart Touch Bidirectional | Cardiac ablation percutaneous catheter | 213 | 0 |
| VARIPULSE Bi-Directional Catheter | Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation | 378 | 329 |
| Vizigo | Introducer, catheter | 1,598 | 874 |
Device types
The table has the 13 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 .
| Device type | Product code | Reports |
|---|---|---|
| Cardiac ablation percutaneous catheter | LPB | 10,681 |
| Catheter, electrode recording, or probe, electrode recording | DRF | 1,462 |
| Catheter, intracardiac mapping, high-density array | MTD | 1,588 |
| Catheter, intravascular, diagnostic | DQO | 20 |
| Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | OAE | 1,864 |
| Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | OAD | 934 |
| Catheter, recording, electrode, reprocessed | NLH | 5 |
| Catheter, ultrasound, intravascular | OBJ | 496 |
| Computer, diagnostic, programmable | DQK | 653 |
| Ear, nose, and throat stereotaxic instrument | PGW | 17 |
| Electrode, pacemaker, temporary | LDF | 23 |
| Introducer, catheter | DYB | 6,354 |
| Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation | QZI | 649 |
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 | 700 | 2.8% | |
| Injury | 9,433 | 38.1% | |
| Malfunction | 14,575 | 58.9% | |
| Other | 20 | 0.1% | |
| Not given | 24 | 0.1% |
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. Biosense Webster: medical device reports that give this manufacturer. https://reportedreactions.com/manufacturer/biosense-webster/ 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 (700), injury (9,433), malfunction (14,575) and other (20). 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 24,752 reports with the name Biosense Webster after the site removes company suffixes. A subsidiary, a plant or a different spelling is a separate name.