2026 data FDA MAUDE openFDA FDA Class III

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 · 11,392 reports · 2009–2026

  • BOOK 11,392 reports
  • RANK #201 of 1000
  • DEATH 347 death-typed
  • INJ 5,463 injury-typed
  • MALF 5,578 malfunction
  • SPAN 2009–2026
  • PEAK 2024: 2,098
  • PHOTO Dermal Cooling Pack/V…

Nearest event-volume peer: Dermal Cooling Pack/Vacuum/Massager (5 report gap)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation sits #201 of 1000 among tracked device types with 11,392 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 →

Injury-coded reports run above the device-type norm

Catheter carries 48.0% INJURY-coded reports, 17.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.0% corpus 1.5% · above corpus mean (+1.5 pp)
  • INJ 48.0% corpus 30.3% · above corpus mean (+17.7 pp)
  • MALF 49.0% corpus 64.8% · below corpus mean (-15.9 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 39% of manufacturer-tagged reports · Top event location is 61% 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 11,392 MAUDE reports, ranked #201 of 1000.

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

Event Types

Malfunction 5,578 (49.0%)
Injury 5,463 (48.0%)
Death 347 (3.0%)
2 (0.0%)
Other 2 (0.0%)

Patient Outcomes

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

5,644 (40.4%)
Required Intervention 2,018 (14.4%)
Other 1,633 (11.7%)
R 1,252 (9.0%)
Hospitalization 940 (6.7%)
L 837 (6.0%)
Life Threatening 721 (5.2%)
H 441 (3.2%)
Death 302 (2.2%)
O 95 (0.7%)
D 52 (0.4%)
Disability 32 (0.2%)
S 7 (0.1%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 4,187
Material Twisted/Bent 970
Patient Device Interaction Problem 934
Material Integrity Problem 714
Device Contamination with Body Fluid 660
Optical Problem 488
Fluid/Blood Leak 378
Protective Measures Problem 351
Communication or Transmission Problem 333
Insufficient Device Problem Information 295
Incorrect, Inadequate or Imprecise Result or Readings 289
Fracture 246
Coagulation in Device or Device Ingredient 203
Material Deformation 189
Appropriate Device Problem Term/Code Not Available 171
Insufficient Cooling 149
Temperature Problem 149
Contamination /Decontamination Problem 137
Gas/Air Leak 137
Device Displays Incorrect Message 130

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: 585

Reports in 2025 (1,432) held close to the prior two-year average of 1,705.

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

Event Locations

6,978 (61.3%)
I 4,258 (37.4%)
HOSPITAL 129 (1.1%)
NO INFORMATION 15 (0.1%)
OTHER 12 (0.1%)

Compare MEDTRONIC CRYOCATH LP vs ST. JUDE MEDICAL →

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 (11,392 here).

Similar death-typed counts

Nearest other device types by death-typed report count (347 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.