PlainHospital

BIOSENSE WEBSTER INC

Manufacturer adverse-event records for BIOSENSE WEBSTER INC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2010–2026 · heavy-book · elevated Death-code · balanced

Death-code intensity

BIOSENSE WEBSTER INC carries an elevated Death-code share

Death-coded event_type rows are 551 of 20,407 (2.70% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for BIOSENSE WEBSTER INC

The standout signal for BIOSENSE WEBSTER INC is Death-code intensity: 2.70% of 20,407 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BIOSENSE WEBSTER INC with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 15 device types, led in this extract by Malfunction at 11,862 (58.1% of event_type total). Peak single-year volume reaches 3,906 reports across 15 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

20,407
Total Reports
551
Event-type Death
7,989
Injury Reports
15
Device Types

Event Types

Malfunction 11,862 (58.1%)
Injury 7,989 (39.1%)
Death 551 (2.7%)
3 (0.0%)
No answer provided 1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

11,843 (40.4%)
R 4,411 (15.1%)
Life Threatening 3,540 (12.1%)
L 2,980 (10.2%)
Required Intervention 2,085 (7.1%)
Hospitalization 1,791 (6.1%)
H 1,331 (4.5%)
Other 712 (2.4%)
Death 385 (1.3%)
D 167 (0.6%)
S 35 (0.1%)
O 21 (0.1%)
Congenital Anomaly 1 (0.0%)

Devices (15)

Device Reports
Cardiac Ablation Percutaneous Catheter 8,963
Introducer, Catheter 5,486
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation 1,608
Catheter, Intracardiac Mapping, High-Density Array 1,339
Catheter, Electrode Recording, Or Probe, Electrode Recording 992
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter 727
Computer, Diagnostic, Programmable 530
Catheter, Ultrasound, Intravascular 359
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation 344
Ear, Nose, And Throat Stereotaxic Instrument 21
Electrode, Pacemaker, Temporary 20
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material 7
Catheter, Percutaneous 1
Dilator, Vessel, For Percutaneous Catheterization 1
Trocar 1

Yearly Trend

10
2010: 1
13
2013: 1
14
2014: 15
15
2015: 1
16
2016: 9
17
2017: 438
18
2018: 1,056
19
2019: 1,044
20
2020: 1,347
21
2021: 2,213
22
2022: 3,290
23
2023: 3,031
24
2024: 3,906
25
2025: 3,512
26
2026: 543

Read our methodology - how this data is sourced, computed, and verified.