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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#631 of 1000 · 1,095 reports · 1992–2026

  • BOOK 1,095 reports
  • RANK #631 of 1000
  • DEATH 6 death-typed
  • INJ 269 injury-typed
  • MALF 805 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 124
  • PHOTO Growing Rod System- M…

Nearest event-volume peer: Growing Rod System- Magnetic Actuation (1 report gap)

Dilator, Catheter, Ureteral sits #631 of 1000 among tracked device types with 1,095 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 24.6% corpus 30.4% · below corpus mean (-5.9 pp)
  • MALF 73.5% corpus 64.5% · above corpus mean (+9.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 20% 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 1,095 MAUDE reports, ranked #631 of 1000.

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

Event Types

Malfunction 805 (73.5%)
Injury 269 (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.

656 (54.7%)
Other 214 (17.8%)
Required Intervention 158 (13.2%)
Hospitalization 56 (4.7%)
R 45 (3.8%)
O 33 (2.8%)
H 27 (2.3%)
Death 6 (0.5%)
Disability 2 (0.2%)
S 1 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 113
Burst Container or Vessel 86
Fluid/Blood Leak 63
Inflation Problem 50
Material Rupture 40
Material Puncture/Hole 33
Leak/Splash 31
Break 26
Material Fragmentation 26
Component Misassembled 17
Kinked 17
Deflation Problem 15
Device Handling Problem 15
Difficult to Remove 10
Material Split, Cut or Torn 9
Device Contamination with Chemical or Other Material 6
Device Packaging Compromised 6
Pressure Problem 6
Fracture 5
Gas/Air Leak 5

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: 5

Related Entities for Dilator, Catheter, Ureteral

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 265
C.R. BARD, INC. (COVINGTON) -1018233 240
BOSTON SCIENTIFIC - GALWAY 177
BOSTON SCIENTIFIC 55
COOK INC 39
BOSTON SCIENTIFIC - SPENCER 31
C.R. BARD INC. (COVINGTON) -1018233 29
BOSTON SCIENTIFIC CORP 18
BOSTON SCIENTIFIC CORP. 18

Event Locations

711 (64.9%)
I 259 (23.7%)
HOSPITAL 111 (10.1%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Dilator, Catheter, Ureteral, 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 (1,095 here).

Growing Rod System- Magnetic Actuation 1,094 System, Irrigation, Urological 1,093 Light Adjustable Lens And Light Delivery De… 1,092 Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1,092

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 Device, Percutaneous Retrieval 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.