2026 data FDA MAUDE openFDA

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

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 MID-BOOK · MAUDE

#201 of 1000 · 10,969 reports · 2009–2026

  • BOOK 10,969 reports
  • RANK #201 of 1000
  • DEATH 335 death-typed
  • INJ 5,260 injury-typed
  • MALF 5,370 malfunction
  • SPAN 2009–2026
  • PEAK 2024: 2,098
  • PHOTO Image-Intensified Flu…

Nearest event-volume peer: Image-Intensified Fluoroscopic X-Ray System, Mobile (10 report gap)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation sits #201 of 1000 among tracked device types with 10,969 MAUDE reports spanning 2009–2026. 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 3.1% corpus 1.5% · above corpus mean (+1.5 pp)
  • INJ 48.0% corpus 30.4% · above corpus mean (+17.5 pp)
  • MALF 49.0% corpus 64.5% · below corpus mean (-15.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 38% of coded problems · Lead manufacturer MEDTRONIC CRYOCATH LP accounts for 41% of manufacturer-tagged reports · Top event location is 60% 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 Fibrillation carries 10,969 MAUDE reports, ranked #201 of 1000.

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

Event Types

Malfunction 5,370 (49.0%)
Injury 5,260 (48.0%)
Death 335 (3.1%)
2 (0.0%)
Other 2 (0.0%)

Patient Outcomes

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

5,464 (40.4%)
Required Intervention 1,953 (14.4%)
Other 1,605 (11.9%)
R 1,217 (9.0%)
Hospitalization 922 (6.8%)
L 793 (5.9%)
Life Threatening 684 (5.1%)
H 418 (3.1%)
Death 299 (2.2%)
O 90 (0.7%)
D 48 (0.4%)
Disability 31 (0.2%)
S 7 (0.1%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 3,949
Material Twisted/Bent 944
Patient Device Interaction Problem 826
Material Integrity Problem 696
Device Contamination with Body Fluid 638
Optical Problem 467
Fluid/Blood Leak 350
Protective Measures Problem 332
Communication or Transmission Problem 313
Incorrect, Inadequate or Imprecise Result or Readings 270
Fracture 241
Coagulation in Device or Device Ingredient 199
Material Deformation 181
Appropriate Term/Code Not Available 163
Insufficient Cooling 139
Temperature Problem 139
Gas/Air Leak 132
Contamination /Decontamination Problem 125
Electrical Shorting 121
Excessive Cooling 108

Yearly Trend

09
2009: 2
11
2011: 69
12
2012: 70
13
2013: 111
14
2014: 131
15
2015: 274
16
2016: 311
17
2017: 387
18
2018: 884
19
2019: 908
20
2020: 744
21
2021: 914
22
2022: 1,161
23
2023: 1,311
24
2024: 2,098
25
2025: 1,432
26
2026: 162

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

Event Locations

6,561 (59.8%)
I 4,258 (38.8%)
HOSPITAL 123 (1.1%)
NO INFORMATION 15 (0.1%)
OTHER 12 (0.1%)

Compare MEDTRONIC CRYOCATH LP vs ST. JUDE MEDICAL →

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 (10,969 here).

Similar death-typed counts

Nearest other device types by death-typed report count (335 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.