2026 data FDA MAUDE openFDA

Catheter, Angioplasty, Peripheral, Transluminal

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

#96 of 1000 · 34,818 reports · 1992–2026

  • BOOK 34,818 reports
  • RANK #96 of 1000
  • DEATH 179 death-typed
  • INJ 5,323 injury-typed
  • MALF 28,997 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 2,492
  • PHOTO Stretcher, Wheeled

Nearest event-volume peer: Stretcher, Wheeled (33 report gap)

Catheter, Angioplasty, Peripheral, Transluminal sits #96 of 1000 among tracked device types with 34,818 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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 15.3% corpus 30.4% · below corpus mean (-15.2 pp)
  • MALF 83.3% corpus 64.5% · above corpus mean (+18.8 pp)

Lead product-problem code Material Rupture is 48% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 33% of manufacturer-tagged reports · Top event location is 49% 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, Angioplasty, Peripheral, Transluminal carries 34,818 MAUDE reports, ranked #96 of 1000.

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

Event Types

Malfunction 28,997 (83.3%)
Injury 5,323 (15.3%)
Other 234 (0.7%)
Death 179 (0.5%)
85 (0.2%)

Patient Outcomes

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

28,779 (80.1%)
Required Intervention 3,788 (10.5%)
Other 1,039 (2.9%)
R 774 (2.2%)
Hospitalization 677 (1.9%)
Life Threatening 246 (0.7%)
L 212 (0.6%)
Death 185 (0.5%)
O 78 (0.2%)
S 66 (0.2%)
Disability 49 (0.1%)
H 37 (0.1%)
Invalid Data 4 (0.0%)
D 3 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Material Rupture 11,972
Burst Container or Vessel 3,389
Leak/Splash 1,456
Difficult to Remove 1,269
Detachment of Device or Device Component 1,078
Adverse Event Without Identified Device or Use Problem 788
Deflation Problem 755
Break 696
Inflation Problem 664
Material Separation 455
Material Deformation 415
Difficult to Advance 298
Improper or Incorrect Procedure or Method 281
Failure to Advance 270
Retraction Problem 243
Entrapment of Device 240
Detachment Of Device Component 239
Material Split, Cut or Torn 160
Material Puncture/Hole 158
Fluid/Blood Leak 133

Yearly Trend

92
1992: 8
93
1993: 11
94
1994: 22
95
1995: 30
96
1996: 269
97
1997: 597
98
1998: 231
99
1999: 187
00
2000: 334
01
2001: 462
02
2002: 437
03
2003: 439
04
2004: 530
05
2005: 618
06
2006: 872
07
2007: 577
08
2008: 513
09
2009: 623
10
2010: 808
11
2011: 857
12
2012: 1,276
13
2013: 1,242
14
2014: 1,178
15
2015: 1,279
16
2016: 1,529
17
2017: 2,081
18
2018: 2,188
19
2019: 2,405
20
2020: 2,443
21
2021: 2,492
22
2022: 2,155
23
2023: 1,807
24
2024: 1,913
25
2025: 2,094
26
2026: 311

Related Entities for Catheter, Angioplasty, Peripheral, Transluminal

Event Locations

17,192 (49.4%)
I 13,122 (37.7%)
HOSPITAL 3,728 (10.7%)
OTHER 484 (1.4%)
UNKNOWN 105 (0.3%)
NO INFORMATION 84 (0.2%)
INVALID DATA 55 (0.2%)
NOT APPLICABLE 28 (0.1%)
OUTPATIENT TREATMENT FACILITY 10 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 8 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
HOME 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - MAPLE GROVE →

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 (34,818 here).

Similar death-typed counts

Nearest other device types by death-typed report count (179 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.