Device manufacturer, as written on reports

Biosense Webster: medical device reports filed with FDA

24,605 reports name it as the manufacturer of the device involved, 2000–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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." And: "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."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

24,605
reports naming it as manufacturer: 0.1% of all MAUDE reports; 3,533
reports, 12 months to August 2026: 3,624 in the 12 months before; 58.8%
classified as malfunction: 62.3% across all reports; 2.8%
classified as death, as reported: 0.9% across all reports

24,605 medical device reports received by FDA give Biosense Webster as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2000 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

3,533 reports arrived in the 12 months to August 2026, close to the 3,624 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (58.8%), injury (38.2%) and death (2.8%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Thermocool Smart Touch Sf Bi-Directional Navigation Catheter	Cardiac ablation percutaneous catheter	4,535	22	4.5%
ThermoCool SmartTouch SF	Cardiac ablation percutaneous catheter	1,721	657	3.8%
Vizigo	Introducer, catheter	1,547	873	0.4%
Carto Vizigo 8 5f Bi-Directional Guiding Sheath Medium	Introducer, catheter	1,381	0	0.1%
QDOT Micro	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	1,168	390	3%
Carto Vizigo 8 5f Bi-Directional Guiding Sheath - Medium	Introducer, catheter	885	19	0.2%
Thermocool Smart Touch Sf Uni-Directional Navigation Catheter	Cardiac ablation percutaneous catheter	875	14	3.7%
Carto Vizigo 8 5f Bi-Directional Guiding Sheath Small	Introducer, catheter	870	0	0%
Thermocool Smart Touch Electrophysiology Catheter	Cardiac ablation percutaneous catheter	713	5	2.8%
Carto Vizigo 8 5f Bi-Directional Guiding Sheath - Small	Introducer, catheter	701	11	0%
Qdot Micro Catheter	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	538	37	3.5%
Pentaray Nav High-Density Mapping Eco Catheter	Catheter, intracardiac mapping, high-density array	532	9	1.3%
Thermocool Smart Touch Bi-Directional Navigation Catheter	Cardiac ablation percutaneous catheter	507	0	8%
Carto 3 System	Computer, diagnostic, programmable	477	23	0.8%
OCTARAY Mapping Catheter	Catheter, intracardiac mapping, high-density array	396	99	1.5%
Pentaray Nav	Catheter, intracardiac mapping, high-density array	388	201	0.8%
VARIPULSE Bi-Directional Catheter	Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation	351	309	1.7%
ThermoCool SmartTouch	Cardiac ablation percutaneous catheter	301	100	2.6%
Unk Navistar Thermocool	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	220	0	4.5%
Unk Smart Touch Bidirectional	Cardiac ablation percutaneous catheter	213	0	1.4%
Soundstar	Catheter, ultrasound, intravascular	168	29	0%
Carto Vizigo 8 5f Bi-Directional Guiding Sheath Large	Introducer, catheter	166	0	0%
Preface Guiding Sheath With Multipurpose Curve	Introducer, catheter	145	0	0.4%
NaviStar ThermoCool	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	134	20	7%
Decanav Electrophysiology Catheter	Catheter, electrode recording, or probe, electrode recording	130	4	3.3%
Navi-Star Thermo-Cool Electrophysiology Catheter	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	116	2	1.9%
Ez Steer Nav Bi-Directional Electrophysiology Catheter	Cardiac ablation percutaneous catheter	82	1	3.8%
Navistar Rmt Thermocool Electrophysiology Catheter	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	58	0	7.1%
Navistar Electrophysiology Catheter	Catheter, electrode recording, or probe, electrode recording	51	0	6%
Thermocool Smarttouch Bi-Directional Navigation Catheter	Cardiac ablation percutaneous catheter	32	0	5%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
LPB	Cardiac ablation percutaneous catheter	10,656	43.3%
DYB	Introducer, catheter	6,296	25.6%
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	1,851	7.5%
MTD	Catheter, intracardiac mapping, high-density array	1,579	6.4%
DRF	Catheter, electrode recording, or probe, electrode recording	1,459	5.9%
OAD	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	931	3.8%
DQK	Computer, diagnostic, programmable	650	2.6%
QZI	Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation	619	2.5%
OBJ	Catheter, ultrasound, intravascular	493	2%
LDF	Electrode, pacemaker, temporary	23	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death2.8%698

Injury38.2%9,388

Malfunction58.8%14,475

Other0.1%20

Not given0.1%24

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Biosense Webster reports

How many FDA device reports name Biosense Webster as manufacturer?

24,605 reports through August 2026, 3,533 of them in the latest 12 months.

Which of its brands appear most often?

Thermocool Smart Touch Sf Bi-Directional Navigation Catheter (4,535), ThermoCool SmartTouch SF (1,721), Vizigo (1,547), Carto Vizigo 8 5f Bi-Directional Guiding Sheath Medium (1,381) and QDOT Micro (1,168).

Which device types does it report on?

cardiac ablation percutaneous catheter (43.3%), introducer, catheter (25.6%), catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation (7.5%) and catheter, intracardiac mapping, high-density array (6.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.