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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#444 of 1000 · 2,398 reports · 1992–2026

  • BOOK 2,398 reports
  • RANK #444 of 1000
  • DEATH 23 death-typed
  • INJ 472 injury-typed
  • MALF 1,900 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 409
  • PHOTO Tube, Bronchial

Nearest event-volume peer: Tube, Bronchial (W/Wo Connector) (0 report gap)

Stylet For Catheter, Gastro-Urology sits #444 of 1000 among tracked device types with 2,398 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 1.0% corpus 1.5% · below corpus mean (-0.6 pp)
  • INJ 19.7% corpus 30.4% · below corpus mean (-10.8 pp)
  • MALF 79.2% corpus 64.5% · above corpus mean (+14.7 pp)

Lead product-problem code Flaked is 15% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - COSTA RICA (COYOL) 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 2,398 MAUDE reports, ranked #444 of 1000.

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

Event Types

Malfunction 1,900 (79.2%)
Injury 472 (19.7%)
Death 23 (1.0%)
2 (0.1%)
Other 1 (0.0%)

Patient Outcomes

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

1,577 (64.2%)
Other 553 (22.5%)
Required Intervention 188 (7.7%)
Hospitalization 39 (1.6%)
R 38 (1.5%)
Death 24 (1.0%)
H 19 (0.8%)
O 14 (0.6%)
S 2 (0.1%)
Disability 1 (0.0%)

Top Product Problems

Flaked 175
Break 169
Adverse Event Without Identified Device or Use Problem 156
Detachment of Device or Device Component 153
Device Damaged by Another Device 66
Material Integrity Problem 65
Peeled/Delaminated 63
Material Fragmentation 61
Material Protrusion/Extrusion 38
Material Deformation 37
Unraveled Material 35
Difficult to Advance 31
Material Twisted/Bent 28
Detachment Of Device Component 27
Improper Chemical Reaction 27
Entrapment of Device 14
Difficult to Insert 13
Difficult to Remove 13
Device Contamination with Chemical or Other Material 11
Use of Device Problem 10

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: 15

Related Entities for Stylet For Catheter, Gastro-Urology

Top Manufacturers

BOSTON SCIENTIFIC - COSTA RICA (COYOL) 547
BOSTON SCIENTIFIC CORPORATION 536
C.R. BARD, INC. (COVINGTON) -1018233 280
BOSTON SCIENTIFIC 230
C.R. BARD INC. (COVINGTON) -1018233 69

Event Locations

1,969 (82.1%)
I 348 (14.5%)
HOSPITAL 54 (2.3%)
NO INFORMATION 19 (0.8%)
OTHER 7 (0.3%)
NOT APPLICABLE 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stylet For Catheter, Gastro-Urology, 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 (2,398 here).

Tube, Bronchial 2,398 System, Imaging, Pulsed Doppler, Ultrasonic 2,413 Mattress 2,417 Staple, Fixation, Bone 2,423

Similar death-typed counts

Nearest other device types by death-typed report count (23 here), distinct from the volume row.

Cannula, Catheter 23 Electrode, Electrocardiograph 23 Regulator, Pressure, Gas Cylinder 23 Transducer, Ultrasonic, Diagnostic 23

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.