Device manufacturer, as written on reports

Biosense Webster Irwindale: medical device reports filed with FDA

1,956 reports name it as the manufacturer of the device involved, 2007–2017.

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.

1,956
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 19.7%
classified as malfunction: 62.3% across all reports; 7.2%
classified as death, as reported: 0.9% across all reports

1,956 medical device reports received by FDA give Biosense Webster Irwindale as the manufacturer of the device involved, 0% of the MAUDE database, from October 2007 to September 2017. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none in 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 injury (73.1%), malfunction (19.7%) and death (7.2%). 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
NaviStar ThermoCool	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	462	20	7%
Thermocool Sf Nav Bi-Directional Catheter	Cardiac ablation percutaneous catheter	193	0	6.3%
Thermocool Smarttouch Bi-Directional Navigation Catheter	Cardiac ablation percutaneous catheter	87	0	5%
Ez Steer Thermocool Nav Bi-Directional Catheter	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	79	0	6.3%
Navistar Electrophysiology Catheter	Catheter, electrode recording, or probe, electrode recording	67	0	6%
Preface Guiding Sheath With Multipurpose Curve	Introducer, catheter	44	0	0.4%
Navi-Star Thermo-Cool Electrophysiology Catheter	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	40	2	1.9%
Navistar Rmt Thermocool Electrophysiology Catheter	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	39	0	7.1%
Lasso 2515 Nav Variable Catheter	Catheter, electrode recording, or probe, electrode recording	38	0	0.5%
Thermocool Smarttouch Uni-Directional Navigation Catheter	Cardiac ablation percutaneous catheter	36	0	4.1%
Thermocool Sf Nav Uni-Directional Catheter	Cardiac ablation percutaneous catheter	35	0	4.1%
Thermocool Smarttouch Sf Bi-Directional Nav Catheter	Cardiac ablation percutaneous catheter	24	0	3.4%
Ez Steer Nav Bi-Directional Electrophysiology Catheter	Cardiac ablation percutaneous catheter	18	1	3.8%
Decanav Electrophysiology Catheter	Catheter, electrode recording, or probe, electrode recording	2	4	3.3%

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	897	45.9%
OAD	Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	502	25.7%
DRF	Catheter, electrode recording, or probe, electrode recording	385	19.7%
DYB	Introducer, catheter	56	2.9%
OBJ	Catheter, ultrasound, intravascular	48	2.5%
DQK	Computer, diagnostic, programmable	36	1.8%
MTD	Catheter, intracardiac mapping, high-density array	22	1.1%
GEI	Electrosurgical, cutting & coagulation & accessories	4	0.2%
NLH	Catheter, recording, electrode, reprocessed	2	0.1%
DYG	Catheter, flow directed	1	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

Death7.2%140

Injury73.1%1,429

Malfunction19.7%386

Other0%0

Not given0.1%1

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 Irwindale reports

How many FDA device reports name Biosense Webster Irwindale as manufacturer?

1,956 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

NaviStar ThermoCool (462), Thermocool Sf Nav Bi-Directional Catheter (193), Thermocool Smarttouch Bi-Directional Navigation Catheter (87), Ez Steer Thermocool Nav Bi-Directional Catheter (79) and Navistar Electrophysiology Catheter (67).

Which device types does it report on?

cardiac ablation percutaneous catheter (45.9%), catheter, percutaneous, cardiac ablation, for treatment of atrial flutter (25.7%), catheter, electrode recording, or probe, electrode recording (19.7%) and introducer, catheter (2.9%).

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.