2026 data FDA MAUDE openFDA

Dilator, Vessel, For Percutaneous Catheterization

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 Dilator LIGHT-BOOK · MAUDE

#401 of 1000 · 2,929 reports · 1993–2026

  • BOOK 2,929 reports
  • RANK #401 of 1000
  • DEATH 165 death-typed
  • INJ 1,547 injury-typed
  • MALF 1,200 malfunction
  • SPAN 1993–2026
  • PEAK 2023: 386
  • PHOTO Test, Hepatitis B

Nearest event-volume peer: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) (9 report gap)

Dilator, Vessel, For Percutaneous Catheterization sits #401 of 1000 among tracked device types with 2,929 MAUDE reports spanning 1993–2026. 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 5.6% corpus 1.5% · above corpus mean (+4.1 pp)
  • INJ 52.8% corpus 30.4% · above corpus mean (+22.4 pp)
  • MALF 41.0% corpus 64.5% · below corpus mean (-23.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 30% of coded problems · Lead manufacturer CORDIS DE MEXICO accounts for 34% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Dilator in the event-volume neighbourhood

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

reports

What this shows Dilator, Vessel, For Percutaneous Catheterization carries 2,929 MAUDE reports, ranked #401 of 1000.

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

Event Types

Injury 1,547 (52.8%)
Malfunction 1,200 (41.0%)
Death 165 (5.6%)
11 (0.4%)
Other 6 (0.2%)

Patient Outcomes

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

1,166 (30.3%)
Required Intervention 861 (22.4%)
R 417 (10.8%)
Other 265 (6.9%)
Hospitalization 262 (6.8%)
L 251 (6.5%)
Life Threatening 239 (6.2%)
H 166 (4.3%)
Death 128 (3.3%)
O 49 (1.3%)
D 34 (0.9%)
S 7 (0.2%)
Disability 2 (0.1%)
Invalid Data 2 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 662
Fracture 222
Material Separation 161
Detachment of Device or Device Component 152
Break 109
Physical Resistance/Sticking 109
Difficult to Remove 102
Positioning Problem 102
Device-Device Incompatibility 93
Difficult to Advance 82
Defective Device 81
Device Contamination with Chemical or Other Material 63
Material Deformation 63
Entrapment of Device 41
Material Perforation 35
Material Integrity Problem 32
Detachment Of Device Component 27
Mechanical Jam 20
Crack 19
Nonstandard Device 19

Yearly Trend

93
1993: 3
94
1994: 2
98
1998: 4
99
1999: 3
00
2000: 11
01
2001: 108
02
2002: 10
03
2003: 4
04
2004: 7
05
2005: 30
06
2006: 23
07
2007: 81
08
2008: 38
09
2009: 69
10
2010: 73
11
2011: 90
12
2012: 132
13
2013: 120
14
2014: 82
15
2015: 82
16
2016: 84
17
2017: 101
18
2018: 126
19
2019: 144
20
2020: 120
21
2021: 115
22
2022: 136
23
2023: 386
24
2024: 325
25
2025: 356
26
2026: 64

Related Entities for Dilator, Vessel, For Percutaneous Catheterization

Event Locations

1,875 (64.0%)
I 624 (21.3%)
HOSPITAL 265 (9.0%)
UNKNOWN 109 (3.7%)
NO INFORMATION 36 (1.2%)
HOME 7 (0.2%)
OUTPATIENT TREATMENT FACILITY 4 (0.1%)
INVALID DATA 3 (0.1%)
CATHETERIZATION SUITE 2 (0.1%)
NOT APPLICABLE 2 (0.1%)
OTHER 2 (0.1%)

Compare CORDIS DE MEXICO vs CORDIS CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Dilator, 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 (2,929 here).

Similar death-typed counts

Nearest other device types by death-typed report count (165 here), distinct from the volume row.

Disclaimer: MAUDE figures for Dilator 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 Dilator; 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.