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2025 data FDA MAUDE openFDA

Accessories, Catheter, G-U

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 Accessories, Catheter, G-U LIGHT-BOOK · MAUDE

#960 of 1000 · 390 reports · 1995–2025

  • BOOK 390 reports
  • RANK #960 of 1000
  • DEATH 2 death-typed
  • INJ 99 injury-typed
  • MALF 276 malfunction
  • SPAN 1995–2025
  • PEAK 2004: 61
  • PHOTO Bag

Nearest event-volume peer: Bag, Urine Collection, Leg, For External Use, Sterile (0 report gap)

Accessories, Catheter, G-U sits #960 of 1000 among tracked device types with 390 MAUDE reports spanning 1995–2025. 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 25.4% corpus 30.4% · below corpus mean (-5.1 pp)
  • MALF 70.8% corpus 64.5% · above corpus mean (+6.3 pp)

Lead product-problem code Break is 49% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORP. accounts for 32% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Accessories, Catheter, G-U in the event-volume neighbourhood

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

reports

What this shows Accessories, Catheter, G-U carries 390 MAUDE reports, ranked #960 of 1000.

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

Event Types

Malfunction 276 (70.8%)
Injury 99 (25.4%)
Other 8 (2.1%)
5 (1.3%)
Death 2 (0.5%)

Patient Outcomes

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

236 (58.3%)
Other 72 (17.8%)
Required Intervention 66 (16.3%)
Hospitalization 12 (3.0%)
R 11 (2.7%)
O 3 (0.7%)
Disability 3 (0.7%)
L 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Break 88
Fracture 15
Material Separation 14
Detachment of Device or Device Component 8
Device Fell 8
Material Fragmentation 7
Adverse Event Without Identified Device or Use Problem 6
Split 6
Detachment Of Device Component 5
Peeled/Delaminated 5
Material Twisted/Bent 4
Difficult to Insert 3
Material Integrity Problem 3
Device Contamination with Chemical or Other Material 2
Physical Resistance 2
Appropriate Term/Code Not Available 1
Crack 1
Defective Component 1
Defective Device 1
Deflation Problem 1

Yearly Trend

95
1995: 1
97
1997: 3
98
1998: 2
00
2000: 3
01
2001: 6
02
2002: 5
03
2003: 3
04
2004: 61
05
2005: 21
06
2006: 21
07
2007: 15
08
2008: 19
09
2009: 10
10
2010: 12
11
2011: 6
12
2012: 5
13
2013: 8
14
2014: 7
15
2015: 13
16
2016: 19
17
2017: 21
18
2018: 17
19
2019: 19
20
2020: 36
21
2021: 17
22
2022: 19
23
2023: 13
24
2024: 5
25
2025: 3

Related Entities for Accessories, Catheter, G-U

Top Manufacturers

BOSTON SCIENTIFIC CORP. 55
BOSTON SCIENTIFIC 43
GYRUS ACMI, INC. 42
APPLIED MEDICAL RESOURCES 10
GYRUS ACMI, INC 9
BOSTON SCIENTIFIC CORPORATION 7
COOK ENDOSCOPY 7

Event Locations

169 (43.3%)
I 110 (28.2%)
HOSPITAL 96 (24.6%)
NO INFORMATION 10 (2.6%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.5%)
UNKNOWN 2 (0.5%)
HOME 1 (0.3%)

Compare BOSTON SCIENTIFIC CORP. vs BOSTON SCIENTIFIC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Accessories, Catheter, G-U, 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 (390 here).

Bag 390 Coagulator-Cutter, Endoscopic, Unipolar 391 Controller, Foot, Handpiece And Cord 388 Lead, Atomic Absorption 388

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Soft Lens Products 2 Analyzer, Chemistry Clinical Use 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Accessories, Catheter, G-U 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 Accessories, Catheter, G-U; 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.