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2026 data FDA MAUDE openFDA

Catheter, Ultrasound, Intravascular

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.

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FDA MAUDE casebook

openFDA event book Catheter, Ultrasound, Intravascular LIGHT-BOOK · MAUDE

#249 of 1000 · 7,328 reports · 2004–2026

  • BOOK 7,328 reports
  • RANK #249 of 1000
  • DEATH 72 death-typed
  • INJ 1,022 injury-typed
  • MALF 6,214 malfunction
  • SPAN 2004–2026
  • PEAK 2024: 1,154
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (10 report gap)

Catheter, Ultrasound, Intravascular sits #249 of 1000 among tracked device types with 7,328 MAUDE reports spanning 2004–2026. 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 1.0% corpus 1.5% · below corpus mean (-0.5 pp)
  • INJ 13.9% corpus 30.4% · below corpus mean (-16.5 pp)
  • MALF 84.8% corpus 64.5% · above corpus mean (+20.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 17% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 72% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Catheter, Ultrasound, Intravascular in the event-volume neighbourhood

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

reports

What this shows Catheter, Ultrasound, Intravascular carries 7,328 MAUDE reports, ranked #249 of 1000.

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

Event Types

Malfunction 6,214 (84.8%)
Injury 1,022 (13.9%)
Death 72 (1.0%)
Other 15 (0.2%)
4 (0.1%)
No answer provided 1 (0.0%)

Patient Outcomes

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

6,150 (79.5%)
Required Intervention 608 (7.9%)
R 243 (3.1%)
Other 234 (3.0%)
L 130 (1.7%)
Life Threatening 130 (1.7%)
Hospitalization 118 (1.5%)
Death 67 (0.9%)
H 31 (0.4%)
O 20 (0.3%)
D 6 (0.1%)
S 2 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,196
Entrapment of Device 878
Poor Quality Image 854
Detachment of Device or Device Component 642
Retraction Problem 397
No Display/Image 394
Material Deformation 340
Fracture 335
Material Twisted/Bent 331
Material Separation 312
Material Integrity Problem 299
Failure to Advance 216
Air/Gas in Device 180
Difficult to Flush 153
Physical Resistance/Sticking 147
Patient Device Interaction Problem 119
Unable to Obtain Readings 103
Nonstandard Device 87
Contamination /Decontamination Problem 83
Use of Device Problem 83

Yearly Trend

04
2004: 1
08
2008: 6
09
2009: 22
10
2010: 39
11
2011: 47
12
2012: 53
13
2013: 328
14
2014: 609
15
2015: 401
16
2016: 515
17
2017: 524
18
2018: 542
19
2019: 237
20
2020: 288
21
2021: 353
22
2022: 473
23
2023: 697
24
2024: 1,154
25
2025: 797
26
2026: 242

Related Entities for Catheter, Ultrasound, Intravascular

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 3,014
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 544
BIOSENSE WEBSTER INC 359
ST. JUDE MEDICAL 179
ST. JUDE MEDICAL, INC. 118

Event Locations

4,584 (62.6%)
I 2,241 (30.6%)
HOSPITAL 450 (6.1%)
OTHER 35 (0.5%)
NO INFORMATION 15 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - COSTA RICA (COYOL) →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Ultrasound, Intravascular, 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 (7,328 here).

Catheter 7,318 Abutment, Implant, Dental, Endosseous 7,311 Cystoscope And Accessories, Flexible/Rigid 7,356 Lens, Intraocular, Toric Optics 7,256

Similar death-typed counts

Nearest other device types by death-typed report count (72 here), distinct from the volume row.

Catheter, Hemodialysis, Non-Implanted 72 Intestinal Stimulator 72 Prosthesis 72 Ligator, Esophageal 71

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Catheter, Ultrasound, Intravascular 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, Ultrasound, Intravascular; 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.