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2026 data FDA MAUDE openFDA FDA Class II

Stent, 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 §876.4620 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Stent, Ureteral LIGHT-BOOK · MAUDE

#294 of 1000 · 5,858 reports · 1993–2026

  • BOOK 5,858 reports
  • RANK #294 of 1000
  • DEATH 9 death-typed
  • INJ 1,678 injury-typed
  • MALF 4,128 malfunction
  • SPAN 1993–2026
  • PEAK 2023: 691
  • PHOTO Ultrasound Bronchosco…

Nearest event-volume peer: Ultrasound Bronchoscope (2 report gap)

Stent, Ureteral sits #294 of 1000 among tracked device types with 5,858 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 →

Malfunction reports run above the device-type norm

Stent, Ureteral carries 70.5% MALFUNCTION-coded reports, 5.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 28.6% corpus 30.3% · below corpus mean (-1.6 pp)
  • MALF 70.5% corpus 64.8% · above corpus mean (+5.6 pp)

Lead product-problem code Break is 26% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 31% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Stent, Ureteral in the event-volume neighbourhood

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

reports

What this shows Stent, Ureteral carries 5,858 MAUDE reports, ranked #294 of 1000.

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

Event Types

Malfunction 4,128 (70.5%)
Injury 1,678 (28.6%)
Other 30 (0.5%)
13 (0.2%)
Death 9 (0.2%)

Patient Outcomes

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

3,061 (50.4%)
Other 1,421 (23.4%)
Required Intervention 1,158 (19.1%)
Hospitalization 154 (2.5%)
R 142 (2.3%)
H 40 (0.7%)
O 33 (0.5%)
Life Threatening 23 (0.4%)
L 19 (0.3%)
Death 10 (0.2%)
Disability 7 (0.1%)
S 4 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 1,407
Material Fragmentation 599
Calcified 469
Adverse Event Without Identified Device or Use Problem 412
Difficult to Remove 404
Material Separation 249
Material Split, Cut or Torn 228
Difficult to Advance 211
Detachment of Device or Device Component 205
Material Deformation 198
Migration 171
Deformation Due to Compressive Stress 167
Patient Device Interaction Problem 129
Fracture 127
Biocompatibility 101
Migration or Expulsion of Device 101
Detachment Of Device Component 98
Replace 87
Device Damaged Prior to Use 77
Torn Material 74

Yearly Trend

93
1993: 1
94
1994: 3
95
1995: 6
96
1996: 22
97
1997: 16
98
1998: 22
99
1999: 26
00
2000: 11
01
2001: 10
02
2002: 16
03
2003: 18
04
2004: 22
05
2005: 58
06
2006: 81
07
2007: 43
08
2008: 76
09
2009: 123
10
2010: 78
11
2011: 95
12
2012: 131
13
2013: 82
14
2014: 78
15
2015: 130
16
2016: 182
17
2017: 265
18
2018: 277
19
2019: 261
20
2020: 352
21
2021: 531
22
2022: 559
23
2023: 691
24
2024: 603
25
2025: 636
26
2026: 353

Reports in 2025 (636) held close to the prior two-year average of 647.

Related Entities for Stent, Ureteral

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 1,541
C.R. BARD, INC. (COVINGTON) -1018233 1,271
COOK INC 849
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 346
C.R. BARD INC. (COVINGTON) -1018233 330
COOK IRELAND LTD 282
COLOPLAST A/S 209
BOSTON SCIENTIFIC 148
BOSTON SCIENTIFIC - SPENCER 66

Event Locations

3,666 (62.6%)
I 1,337 (22.8%)
HOSPITAL 766 (13.1%)
NO INFORMATION 38 (0.6%)
OTHER 14 (0.2%)
AMBULATORY SURGICAL FACILITY 8 (0.1%)
HOME 7 (0.1%)
NOT APPLICABLE 5 (0.1%)
INVALID DATA 4 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.1%)
OUTPATIENT TREATMENT FACILITY 4 (0.1%)
UNKNOWN 4 (0.1%)
AMBULATORY HEALTH CARE FACILITY 1 (0.0%)

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 Stent, 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 (5,858 here).

Ultrasound Bronchoscope 5,860 Blade 5,861 Drug-Eluting Peripheral Transluminal Angiop… 5,888 Holder, Head, Neurosurgical 5,826

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Stent, 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 Stent, 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.