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2026 data FDA MAUDE openFDA FDA Class II

Catheter, Intracardiac Mapping, High-Density Array

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.1220 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Catheter LIGHT-BOOK · MAUDE

#516 of 1000 · 1,863 reports · 1999–2026

  • BOOK 1,863 reports
  • RANK #516 of 1000
  • DEATH 30 death-typed
  • INJ 535 injury-typed
  • MALF 1,282 malfunction
  • SPAN 1999–2026
  • PEAK 2025: 394
  • PHOTO Disinfectant

Nearest event-volume peer: Disinfectant, Medical Devices (1 report gap)

Catheter, Intracardiac Mapping, High-Density Array sits #516 of 1000 among tracked device types with 1,863 MAUDE reports spanning 1999–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Catheter carries 68.8% MALFUNCTION-coded reports, 4.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.6% corpus 1.5% · near corpus mean (+0.1 pp)
  • INJ 28.7% corpus 30.3% · below corpus mean (-1.6 pp)
  • MALF 68.8% corpus 64.8% · above corpus mean (+4.0 pp)

Lead product-problem code Obstruction of Flow is 23% of coded problems · Lead manufacturer BIOSENSE WEBSTER INC accounts for 85% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .

Catheter in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Catheter, Intracardiac Mapping, High-Density Array carries 1,863 MAUDE reports, ranked #516 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,282 (68.8%)
Injury 535 (28.7%)
Death 30 (1.6%)
Other 15 (0.8%)
1 (0.1%)

Patient Outcomes

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

1,268 (54.0%)
R 237 (10.1%)
Required Intervention 187 (8.0%)
L 179 (7.6%)
Life Threatening 159 (6.8%)
Hospitalization 113 (4.8%)
Other 92 (3.9%)
H 75 (3.2%)
Death 23 (1.0%)
D 7 (0.3%)
O 6 (0.3%)
S 2 (0.1%)
Disability 2 (0.1%)

Top Product Problems

Obstruction of Flow 453
Patient Device Interaction Problem 348
Adverse Event Without Identified Device or Use Problem 154
Entrapment of Device 130
Detachment of Device or Device Component 118
Device Contamination with Body Fluid 87
Contamination /Decontamination Problem 86
Signal Artifact/Noise 83
Material Twisted/Bent 73
Coagulation in Device or Device Ingredient 65
Device-Device Incompatibility 58
Break 49
Material Protrusion/Extrusion 48
Material Separation 42
Display or Visual Feedback Problem 33
Improper or Incorrect Procedure or Method 30
Material Deformation 30
Sharp Edges 30
Communication or Transmission Problem 28
Device Displays Incorrect Message 22

Yearly Trend

99
1999: 1
00
2000: 1
02
2002: 1
03
2003: 7
04
2004: 2
05
2005: 1
06
2006: 3
07
2007: 1
08
2008: 3
09
2009: 6
10
2010: 19
11
2011: 14
12
2012: 17
13
2013: 30
14
2014: 28
15
2015: 36
16
2016: 35
17
2017: 38
18
2018: 49
19
2019: 77
20
2020: 87
21
2021: 99
22
2022: 145
23
2023: 184
24
2024: 378
25
2025: 394
26
2026: 207

Reports rose to 394 in 2025, up from an average of 281 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Intracardiac Mapping, High-Density Array

Top Manufacturers

BIOSENSE WEBSTER INC 1,456
BIOSENSE WEBSTER, INC. (JUAREZ) 91
BIOSENSE WEBSTER INC. 58
ST. JUDE MEDICAL 43
BIOSENSE WEBSTER, INC. 24
ABBOTT MEDICAL 23
ST. JUDE MEDICAL, INC. 10

Event Locations

1,417 (76.1%)
I 359 (19.3%)
HOSPITAL 77 (4.1%)
NO INFORMATION 5 (0.3%)
OTHER 5 (0.3%)

Compare BIOSENSE WEBSTER INC vs BIOSENSE WEBSTER, INC. (JUAREZ) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,863 here).

Disinfectant, Medical Devices 1,864 Tubing, Pump, Cardiopulmonary Bypass 1,866 Bed 1,867 Sterilant, Medical Devices 1,870

Similar death-typed counts

Nearest other device types by death-typed report count (30 here), distinct from the volume row.

Apparatus, Nitric Oxide Delivery 30 Barrier, Absorbable, Adhesion 30 Bed, Patient Rotation, Powered 30 Cannula, Nasal, Oxygen 30

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

Disclaimer: MAUDE figures for Catheter are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Catheter; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.