2026 data FDA MAUDE openFDA FDA Class III

Drug-Coated Peripheral Transluminal Angioplasty Catheter

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 Drug-Coated Peripheral Transluminal Angiopl… LIGHT-BOOK · MAUDE

#873 of 1000 · 526 reports · 2017–2026

  • BOOK 526 reports
  • RANK #873 of 1000
  • DEATH 8 death-typed
  • INJ 416 injury-typed
  • MALF 102 malfunction
  • SPAN 2017–2026
  • PEAK 2025: 273
  • PHOTO Display

Nearest event-volume peer: Display, Cathode-Ray Tube, Medical (1 report gap)

Drug-Coated Peripheral Transluminal Angioplasty Catheter sits #873 of 1000 among tracked device types with 526 MAUDE reports spanning 2017–2026. 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

Drug-Coated Peripheral Transluminal Angiopl… carries 79.1% INJURY-coded reports, 48.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.5% corpus 1.5% · near corpus mean (+0.0 pp)
  • INJ 79.1% corpus 30.3% · above corpus mean (+48.8 pp)
  • MALF 19.4% corpus 64.8% · below corpus mean (-45.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 69% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 99% of manufacturer-tagged reports · Top event location is 90% of location-tagged rows .

Drug-Coated Peripheral Transluminal Angiopl… in the event-volume neighbourhood

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

reports

What this shows Drug-Coated Peripheral Transluminal Angioplasty Catheter carries 526 MAUDE reports, ranked #873 of 1000.

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

Event Types

Injury 416 (79.1%)
Malfunction 102 (19.4%)
Death 8 (1.5%)

Patient Outcomes

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

Required Intervention 385 (67.7%)
85 (14.9%)
Other 37 (6.5%)
R 29 (5.1%)
Death 11 (1.9%)
O 10 (1.8%)
Hospitalization 6 (1.1%)
D 3 (0.5%)
H 1 (0.2%)
L 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 413
Material Rupture 33
Burst Container or Vessel 25
Difficult to Remove 20
Inflation Problem 16
Deflation Problem 13
Device-Device Incompatibility 11
Leak/Splash 11
Detachment of Device or Device Component 10
Material Separation 7
Material Split, Cut or Torn 6
Material Twisted/Bent 6
Material Deformation 5
Retraction Problem 5
Insufficient Device Problem Information 4
Device Markings/Labelling Problem 3
Improper or Incorrect Procedure or Method 3
Break 2
Crack 2
Delivered as Unsterile Product 2

Yearly Trend

17
2017: 2
18
2018: 11
19
2019: 10
20
2020: 16
21
2021: 24
22
2022: 27
23
2023: 31
24
2024: 66
25
2025: 273
26
2026: 66

Reports rose to 273 in 2025, up from an average of 49 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Drug-Coated Peripheral Transluminal Angioplasty Catheter

Event Locations

471 (89.5%)
I 38 (7.2%)
HOSPITAL 16 (3.0%)
NO INFORMATION 1 (0.2%)

Compare MEDTRONIC IRELAND vs BARD PERIPHERAL VASCULAR, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Drug-Coated Peripheral Transluminal Angiopl…: 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 (526 here).

Similar death-typed counts

Nearest other device types by death-typed report count (8 here), distinct from the volume row.

Disclaimer: MAUDE figures for Drug-Coated Peripheral Transluminal Angiopl… 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 Drug-Coated Peripheral Transluminal Angiopl…; 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.