2026 data FDA MAUDE openFDA

Catheter, Electrode Recording, Or Probe, Electrode Recording

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 MAUDE casebook

openFDA event book Catheter LIGHT-BOOK · MAUDE

#229 of 1000 · 8,601 reports · 1992–2026

  • BOOK 8,601 reports
  • RANK #229 of 1000
  • DEATH 300 death-typed
  • INJ 4,070 injury-typed
  • MALF 4,179 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 723
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Continuous Flush (58 report gap)

Catheter, Electrode Recording, Or Probe, Electrode Recording sits #229 of 1000 among tracked device types with 8,601 MAUDE reports spanning 1992–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 3.5% corpus 1.5% · above corpus mean (+2.0 pp)
  • INJ 47.3% corpus 30.4% · above corpus mean (+16.9 pp)
  • MALF 48.6% corpus 64.5% · below corpus mean (-15.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 42% of coded problems · Lead manufacturer BIOSENSE WEBSTER INC accounts for 17% of manufacturer-tagged reports · Top event location is 50% 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, Electrode Recording, Or Probe, Electrode Recording carries 8,601 MAUDE reports, ranked #229 of 1000.

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

Event Types

Malfunction 4,179 (48.6%)
Injury 4,070 (47.3%)
Death 300 (3.5%)
Other 37 (0.4%)
15 (0.2%)

Patient Outcomes

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

4,222 (37.5%)
Required Intervention 1,490 (13.2%)
R 1,467 (13.0%)
Hospitalization 992 (8.8%)
Other 871 (7.7%)
L 828 (7.4%)
Life Threatening 728 (6.5%)
Death 287 (2.5%)
H 235 (2.1%)
O 100 (0.9%)
D 22 (0.2%)
S 14 (0.1%)
Disability 5 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,361
Material Twisted/Bent 780
Patient Device Interaction Problem 389
Material Deformation 355
Entrapment of Device 252
Material Integrity Problem 198
Difficult to Remove 138
Fracture 135
Signal Artifact/Noise 120
Appropriate Term/Code Not Available 114
Break 92
Insufficient Information 90
Material Separation 90
Compatibility Problem 83
Detachment of Device or Device Component 83
Communication or Transmission Problem 81
Mechanical Problem 70
Kinked 69
Fluid/Blood Leak 59
Contamination /Decontamination Problem 58

Yearly Trend

92
1992: 2
96
1996: 20
97
1997: 70
98
1998: 68
99
1999: 28
00
2000: 20
01
2001: 30
02
2002: 20
03
2003: 11
04
2004: 37
05
2005: 47
06
2006: 61
07
2007: 120
08
2008: 176
09
2009: 122
10
2010: 130
11
2011: 244
12
2012: 402
13
2013: 310
14
2014: 349
15
2015: 327
16
2016: 383
17
2017: 458
18
2018: 723
19
2019: 669
20
2020: 651
21
2021: 625
22
2022: 613
23
2023: 685
24
2024: 623
25
2025: 514
26
2026: 63

Related Entities for Catheter, Electrode Recording, Or Probe, Electrode Recording

Event Locations

4,328 (50.3%)
I 3,492 (40.6%)
HOSPITAL 516 (6.0%)
OTHER 242 (2.8%)
NO INFORMATION 12 (0.1%)
INVALID DATA 5 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare BIOSENSE WEBSTER INC vs MEDTRONIC MEXICO S. DE R.L. DE CV →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (8,601 here).

Similar death-typed counts

Nearest other device types by death-typed report count (300 here), distinct from the volume row.

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.