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2026 data FDA MAUDE openFDA FDA Class II

Dilator, Catheter, Ureteral

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 Class II (moderate risk, special controls required), regulated under 21 CFR §876.5470 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Dilator, Catheter, Ureteral LIGHT-BOOK · MAUDE

#640 of 1000 · 1,108 reports · 1992–2026

  • BOOK 1,108 reports
  • RANK #640 of 1000
  • DEATH 6 death-typed
  • INJ 273 injury-typed
  • MALF 814 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 124
  • PHOTO System

Nearest event-volume peer: System, Irrigation, Urological (5 report gap)

Dilator, Catheter, Ureteral sits #640 of 1000 among tracked device types with 1,108 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 →

Malfunction reports run above the device-type norm

Dilator, Catheter, Ureteral carries 73.5% MALFUNCTION-coded reports, 8.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 24.6% corpus 30.3% · below corpus mean (-5.7 pp)
  • MALF 73.5% corpus 64.8% · above corpus mean (+8.6 pp)

Lead product-problem code Burst Container or Vessel is 15% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 30% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Dilator, Catheter, Ureteral in the event-volume neighbourhood

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

reports

What this shows Dilator, Catheter, Ureteral carries 1,108 MAUDE reports, ranked #640 of 1000.

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

Event Types

Malfunction 814 (73.5%)
Injury 273 (24.6%)
9 (0.8%)
Death 6 (0.5%)
Other 6 (0.5%)

Patient Outcomes

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

657 (54.3%)
Other 222 (18.3%)
Required Intervention 160 (13.2%)
Hospitalization 56 (4.6%)
R 45 (3.7%)
O 33 (2.7%)
H 27 (2.2%)
Death 6 (0.5%)
Disability 2 (0.2%)
S 1 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Burst Container or Vessel 161
Adverse Event Without Identified Device or Use Problem 120
Inflation Problem 115
Leak/Splash 80
Balloon burst 71
Fluid/Blood Leak 70
Material Rupture 54
Break 50
Kinked 47
Balloon rupture 44
Material Fragmentation 35
Material Puncture/Hole 35
Balloon leak(s) 30
Deflation Problem 29
Hole In Material 26
Bent 19
Other (for use when an appropriate device code cannot be identified) 19
Difficult to Remove 18
Component Misassembled 17
Device, removal of (non-implant) 16

Yearly Trend

92
1992: 2
93
1993: 2
94
1994: 7
95
1995: 4
96
1996: 3
97
1997: 4
98
1998: 4
99
1999: 8
00
2000: 6
01
2001: 6
02
2002: 10
03
2003: 16
04
2004: 3
05
2005: 14
06
2006: 26
07
2007: 23
08
2008: 53
09
2009: 124
10
2010: 52
11
2011: 54
12
2012: 38
13
2013: 27
14
2014: 28
15
2015: 30
16
2016: 19
17
2017: 65
18
2018: 58
19
2019: 56
20
2020: 40
21
2021: 41
22
2022: 51
23
2023: 83
24
2024: 49
25
2025: 84
26
2026: 18

Reports in 2025 (84) held close to the prior two-year average of 66.

Related Entities for Dilator, Catheter, Ureteral

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 268
C.R. BARD, INC. (COVINGTON) -1018233 239
BOSTON SCIENTIFIC - GALWAY 177
BOSTON SCIENTIFIC 55
C.R. BARD INC. (COVINGTON) -1018233 39
COOK INC 39
BOSTON SCIENTIFIC - SPENCER 31
BOSTON SCIENTIFIC CORP 18
BOSTON SCIENTIFIC CORP. 18

Event Locations

724 (65.3%)
I 259 (23.4%)
HOSPITAL 111 (10.0%)
NO INFORMATION 4 (0.4%)
OTHER 3 (0.3%)
HOME 2 (0.2%)
INVALID DATA 2 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
NOT APPLICABLE 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs C.R. BARD, INC. (COVINGTON) -1018233 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dilator, Catheter, Ureteral: 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 (1,108 here).

System, Irrigation, Urological 1,103 Intervertebral Fusion Device With Bone Graft 1,117 Laryngoscope, Non-Rigid 1,099 Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1,120

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Dressing, Wound, Hydrophilic 6

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

Disclaimer: MAUDE figures for Dilator, Catheter, Ureteral 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, Catheter, Ureteral; 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.