2026 data FDA MAUDE openFDA

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

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

#284 of 1000 · 5,832 reports · 2006–2026

  • BOOK 5,832 reports
  • RANK #284 of 1000
  • DEATH 212 death-typed
  • INJ 2,759 injury-typed
  • MALF 2,834 malfunction
  • SPAN 2006–2026
  • PEAK 2011: 486
  • PHOTO Mesh

Nearest event-volume peer: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling (6 report gap)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter sits #284 of 1000 among tracked device types with 5,832 MAUDE reports spanning 2006–2026. 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 3.6% corpus 1.5% · above corpus mean (+2.1 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 BOSTON SCIENTIFIC CORPORATION accounts for 35% of manufacturer-tagged reports · Top event location is 52% 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, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter carries 5,832 MAUDE reports, ranked #284 of 1000.

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

Event Types

Malfunction 2,834 (48.6%)
Injury 2,759 (47.3%)
Death 212 (3.6%)
21 (0.4%)
Other 6 (0.1%)

Patient Outcomes

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

2,928 (39.5%)
R 969 (13.1%)
Required Intervention 939 (12.7%)
Other 626 (8.5%)
Hospitalization 595 (8.0%)
Life Threatening 520 (7.0%)
L 467 (6.3%)
Death 214 (2.9%)
O 71 (1.0%)
H 53 (0.7%)
S 11 (0.1%)
D 8 (0.1%)
Disability 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,310
Material Integrity Problem 277
Patient Device Interaction Problem 223
Temperature Problem 196
Fluid/Blood Leak 157
Device Displays Incorrect Message 134
Break 97
Communication or Transmission Problem 75
Device Operates Differently Than Expected 72
Improper Flow or Infusion 72
Insufficient Information 65
Leak/Splash 64
Defective Device 63
Obstruction of Flow 58
Signal Artifact/Noise 58
Device Remains Activated 53
Positioning Problem 49
Fracture 40
Impedance Problem 39
Poor Quality Image 38

Yearly Trend

06
2006: 1
07
2007: 2
08
2008: 43
09
2009: 94
10
2010: 406
11
2011: 486
12
2012: 414
13
2013: 256
14
2014: 329
15
2015: 274
16
2016: 239
17
2017: 403
18
2018: 423
19
2019: 475
20
2020: 389
21
2021: 402
22
2022: 344
23
2023: 319
24
2024: 290
25
2025: 196
26
2026: 47

Related Entities for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Event Locations

3,054 (52.4%)
I 2,323 (39.8%)
HOSPITAL 326 (5.6%)
OTHER 119 (2.0%)
NO INFORMATION 8 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BIOSENSE WEBSTER INC →

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 (5,832 here).

Similar death-typed counts

Nearest other device types by death-typed report count (212 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.