2026 data FDA MAUDE openFDA FDA Class I

Stylet, Tracheal Tube

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 §868.5790 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Stylet, Tracheal Tube LIGHT-BOOK · MAUDE

#885 of 1000 · 506 reports · 1992–2026

  • BOOK 506 reports
  • RANK #885 of 1000
  • DEATH 10 death-typed
  • INJ 132 injury-typed
  • MALF 335 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 55
  • PHOTO Bone Grafting Material

Nearest event-volume peer: Bone Grafting Material, Synthetic (1 report gap)

Stylet, Tracheal Tube sits #885 of 1000 among tracked device types with 506 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 →

Injury-coded reports sit below the device-type norm

Stylet, Tracheal Tube carries 26.1% INJURY-coded reports, 4.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.0% corpus 1.5% · near corpus mean (+0.5 pp)
  • INJ 26.1% corpus 30.3% · below corpus mean (-4.2 pp)
  • MALF 66.2% corpus 64.8% · above corpus mean (+1.4 pp)

Lead product-problem code Break is 17% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 74% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Stylet, Tracheal Tube in the event-volume neighbourhood

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

reports

What this shows Stylet, Tracheal Tube carries 506 MAUDE reports, ranked #885 of 1000.

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

Event Types

Malfunction 335 (66.2%)
Injury 132 (26.1%)
Other 22 (4.3%)
Death 10 (2.0%)
7 (1.4%)

Patient Outcomes

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

317 (59.9%)
Required Intervention 96 (18.1%)
Other 57 (10.8%)
R 18 (3.4%)
Life Threatening 12 (2.3%)
Death 10 (1.9%)
Disability 7 (1.3%)
Hospitalization 7 (1.3%)
H 2 (0.4%)
L 2 (0.4%)
S 1 (0.2%)

Top Product Problems

Break 88
Difficult to Remove 73
Detachment Of Device Component 46
Material Fragmentation 38
Material Separation 34
Defective Device 23
Replace 20
Detachment of Device or Device Component 19
Sticking 19
Difficult to Insert 18
Tip breakage 16
Device, removal of (non-implant) 15
Crack 14
Fracture 14
Component(s), broken 13
Design/structure problem 12
Loose 12
Human-Device Interface Problem 11
Inflation Problem 11
Kinked 9

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 1
96
1996: 3
97
1997: 9
98
1998: 9
99
1999: 8
00
2000: 1
01
2001: 32
02
2002: 30
03
2003: 18
04
2004: 3
05
2005: 7
06
2006: 28
07
2007: 16
08
2008: 9
09
2009: 7
10
2010: 18
11
2011: 18
12
2012: 27
13
2013: 35
14
2014: 55
15
2015: 22
16
2016: 9
17
2017: 12
18
2018: 15
19
2019: 18
20
2020: 5
21
2021: 11
22
2022: 5
23
2023: 19
24
2024: 31
25
2025: 18
26
2026: 5

Reports in 2025 (18) held close to the prior two-year average of 25.

Related Entities for Stylet, Tracheal Tube

Top Manufacturers

Event Locations

326 (64.4%)
HOSPITAL 96 (19.0%)
I 60 (11.9%)
OUTPATIENT TREATMENT FACILITY 7 (1.4%)
NO INFORMATION 5 (1.0%)
OTHER 4 (0.8%)
INVALID DATA 3 (0.6%)
NOT APPLICABLE 2 (0.4%)
UNKNOWN 2 (0.4%)
HOME 1 (0.2%)

Compare TELEFLEX MEDICAL vs MMJ SA DE CV (USD) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stylet, Tracheal Tube: 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 (506 here).

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stylet, Tracheal Tube 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, Tracheal Tube; 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.