2026 data FDA MAUDE openFDA

Catheter, Urological

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 Catheter, Urological MID-BOOK · MAUDE

#158 of 1000 · 16,473 reports · 1992–2026

  • BOOK 16,473 reports
  • RANK #158 of 1000
  • DEATH 29 death-typed
  • INJ 2,693 injury-typed
  • MALF 13,353 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 1,873
  • PHOTO Aligner, Sequential

Nearest event-volume peer: Aligner, Sequential (13 report gap)

Catheter, Urological sits #158 of 1000 among tracked device types with 16,473 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 16.3% corpus 30.4% · below corpus mean (-14.1 pp)
  • MALF 81.1% corpus 64.5% · above corpus mean (+16.6 pp)

Lead product-problem code Burst Container or Vessel is 10% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 83% of manufacturer-tagged reports · Top event location is 46% of location-tagged rows .

Catheter, Urological in the event-volume neighbourhood

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

reports

What this shows Catheter, Urological carries 16,473 MAUDE reports, ranked #158 of 1000.

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

Event Types

Malfunction 13,353 (81.1%)
Injury 2,693 (16.3%)
Other 259 (1.6%)
138 (0.8%)
Death 29 (0.2%)
No answer provided 1 (0.0%)

Patient Outcomes

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

8,463 (50.4%)
Other 6,075 (36.2%)
Required Intervention 1,579 (9.4%)
Hospitalization 233 (1.4%)
R 224 (1.3%)
O 61 (0.4%)
Life Threatening 41 (0.2%)
H 30 (0.2%)
Death 27 (0.2%)
Disability 27 (0.2%)
L 14 (0.1%)
S 7 (0.0%)
Invalid Data 4 (0.0%)
Congenital Anomaly 3 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Burst Container or Vessel 1,010
Material Twisted/Bent 717
Difficult to Insert 713
Product Quality Problem 695
Adverse Event Without Identified Device or Use Problem 640
Difficult to Remove 563
Component Missing 562
Material Rupture 541
Device Misassembled During Manufacturing /Shipping 526
Improper Chemical Reaction 475
Deflation Problem 459
Material Integrity Problem 451
Incorrect Measurement 394
Nonstandard Device 378
Device Operates Differently Than Expected 377
Material Puncture/Hole 365
Component Misassembled 364
Short Fill 338
Fluid/Blood Leak 309
Sharp Edges 276

Yearly Trend

92
1992: 22
93
1993: 23
94
1994: 68
95
1995: 89
96
1996: 144
97
1997: 196
98
1998: 114
99
1999: 112
00
2000: 164
01
2001: 208
02
2002: 218
03
2003: 138
04
2004: 94
05
2005: 64
06
2006: 124
07
2007: 180
08
2008: 102
09
2009: 183
10
2010: 228
11
2011: 209
12
2012: 165
13
2013: 393
14
2014: 226
15
2015: 418
16
2016: 284
17
2017: 1,873
18
2018: 1,179
19
2019: 1,167
20
2020: 1,370
21
2021: 1,387
22
2022: 1,280
23
2023: 1,160
24
2024: 1,259
25
2025: 1,419
26
2026: 213

Related Entities for Catheter, Urological

Event Locations

7,556 (45.9%)
I 6,841 (41.5%)
HOSPITAL 1,630 (9.9%)
NO INFORMATION 136 (0.8%)
INVALID DATA 86 (0.5%)
HOME 64 (0.4%)
OTHER 54 (0.3%)
UNKNOWN 53 (0.3%)
NURSING HOME 25 (0.2%)
OUTPATIENT TREATMENT FACILITY 12 (0.1%)
AMBULATORY SURGICAL FACILITY 7 (0.0%)
NOT APPLICABLE 5 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
EMERGENCY ROOM 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Urological, 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 (16,473 here).

Similar death-typed counts

Nearest other device types by death-typed report count (29 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Urological 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, Urological; 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.