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2026 data FDA MAUDE openFDA FDA Class I

Stylet For Catheter, Gastro-Urology

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §876.5130 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Stylet For Catheter, Gastro-Urology LIGHT-BOOK · MAUDE

#453 of 1000 · 2,447 reports · 1992–2026

  • BOOK 2,447 reports
  • RANK #453 of 1000
  • DEATH 24 death-typed
  • INJ 480 injury-typed
  • MALF 1,938 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 409
  • PHOTO Tube, Bronchial

Nearest event-volume peer: Tube, Bronchial (W/Wo Connector) (28 report gap)

Stylet For Catheter, Gastro-Urology sits #453 of 1000 among tracked device types with 2,447 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

Stylet For Catheter, Gastro-Urology carries 79.2% MALFUNCTION-coded reports, 14.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.0% corpus 1.5% · below corpus mean (-0.5 pp)
  • INJ 19.6% corpus 30.3% · below corpus mean (-10.7 pp)
  • MALF 79.2% corpus 64.8% · above corpus mean (+14.4 pp)

Lead product-problem code Detachment Of Device Component is 27% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 33% of manufacturer-tagged reports · Top event location is 82% of location-tagged rows .

Stylet For Catheter, Gastro-Urology in the event-volume neighbourhood

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

reports

What this shows Stylet For Catheter, Gastro-Urology carries 2,447 MAUDE reports, ranked #453 of 1000.

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

Event Types

Malfunction 1,938 (79.2%)
Injury 480 (19.6%)
Death 24 (1.0%)
Other 3 (0.1%)
2 (0.1%)

Patient Outcomes

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

1,595 (63.3%)
Other 591 (23.5%)
Required Intervention 194 (7.7%)
Hospitalization 40 (1.6%)
R 38 (1.5%)
Death 25 (1.0%)
H 20 (0.8%)
O 14 (0.6%)
S 2 (0.1%)
Disability 1 (0.0%)

Top Product Problems

Detachment Of Device Component 684
Peeled/Delaminated 320
Break 243
Flaked 226
Adverse Event Without Identified Device or Use Problem 193
Detachment of Device or Device Component 173
Device Damaged by Another Device 76
Material Integrity Problem 70
Material Fragmentation 69
Device Damaged Prior to Use 68
Device, or device fragments remain in patient 64
Tip breakage 64
Unraveled Material 53
Difficult to Remove 43
Material Protrusion/Extrusion 43
Difficult to Advance 37
Material Deformation 37
Difficult to Insert 35
Source, detachment from 34
Other (for use when an appropriate device code cannot be identified) 31

Yearly Trend

92
1992: 1
97
1997: 3
00
2000: 1
01
2001: 1
03
2003: 1
04
2004: 2
05
2005: 7
06
2006: 35
07
2007: 33
08
2008: 143
09
2009: 409
10
2010: 139
11
2011: 128
12
2012: 109
13
2013: 160
14
2014: 215
15
2015: 53
16
2016: 74
17
2017: 58
18
2018: 46
19
2019: 65
20
2020: 65
21
2021: 69
22
2022: 103
23
2023: 178
24
2024: 133
25
2025: 152
26
2026: 64

Reports in 2025 (152) held close to the prior two-year average of 156.

Related Entities for Stylet For Catheter, Gastro-Urology

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 557
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 547
C.R. BARD, INC. (COVINGTON) -1018233 281
BOSTON SCIENTIFIC 230
C.R. BARD INC. (COVINGTON) -1018233 93

Event Locations

2,018 (82.5%)
I 347 (14.2%)
HOSPITAL 55 (2.2%)
NO INFORMATION 19 (0.8%)
OTHER 7 (0.3%)
NOT APPLICABLE 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - COSTA RICA (COYOL) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stylet For Catheter, Gastro-Urology: 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 (2,447 here).

Tube, Bronchial 2,475 Sensor 2,413 Table, Operating-Room, Ac-Powered 2,406 Suture, Absorbable, Natural 2,489

Similar death-typed counts

Nearest other device types by death-typed report count (24 here), distinct from the volume row.

Apparatus, Suction, Patient Care 24 Catheter, Oximeter, Fiber-Optic 24 Chair, Positioning, Electric 24 Laparoscope, Gynecologic 24

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

Disclaimer: MAUDE figures for Stylet For Catheter, Gastro-Urology 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 Stylet For Catheter, Gastro-Urology; 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.