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2026 data FDA MAUDE openFDA FDA Class II

Cuff, Tracheal Tube, Inflatable

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 II (moderate risk, special controls required), regulated under 21 CFR §868.5750 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Cuff, Tracheal Tube, Inflatable LIGHT-BOOK · MAUDE

#950 of 1000 · 421 reports · 1991–2026

  • BOOK 421 reports
  • RANK #950 of 1000
  • DEATH 9 death-typed
  • INJ 40 injury-typed
  • MALF 371 malfunction
  • SPAN 1991–2026
  • PEAK 2024: 133
  • PHOTO Fibrin Sealant Prepar…

Nearest event-volume peer: Fibrin Sealant Preparation Device (2 report gap)

Cuff, Tracheal Tube, Inflatable sits #950 of 1000 among tracked device types with 421 MAUDE reports spanning 1991–2026. 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

Cuff, Tracheal Tube, Inflatable carries 88.1% MALFUNCTION-coded reports, 23.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
  • INJ 9.5% corpus 30.3% · below corpus mean (-20.8 pp)
  • MALF 88.1% corpus 64.8% · above corpus mean (+23.3 pp)

Lead product-problem code Gas/Air Leak is 39% of coded problems · Lead manufacturer HAMILTON MEDICAL AG accounts for 84% of manufacturer-tagged reports · Top event location is 84% of location-tagged rows .

Cuff, Tracheal Tube, Inflatable in the event-volume neighbourhood

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

reports

What this shows Cuff, Tracheal Tube, Inflatable carries 421 MAUDE reports, ranked #950 of 1000.

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

Event Types

Malfunction 371 (88.1%)
Injury 40 (9.5%)
Death 9 (2.1%)
1 (0.2%)

Patient Outcomes

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

349 (81.4%)
Required Intervention 29 (6.8%)
Other 22 (5.1%)
Death 9 (2.1%)
Hospitalization 7 (1.6%)
Life Threatening 4 (0.9%)
L 3 (0.7%)
R 3 (0.7%)
H 1 (0.2%)
O 1 (0.2%)
Invalid Data 1 (0.2%)

Top Product Problems

Gas/Air Leak 134
Unable to Obtain Readings 33
Break 25
Loose or Intermittent Connection 23
Calibration Problem 13
Electrical /Electronic Property Problem 12
Leak/Splash 12
Component Missing 11
Insufficient Device Problem Information 11
Failure to Zero 10
Decrease in Pressure 9
Pressure Problem 8
Device Operates Differently Than Expected 7
Fire 6
Inflation Problem 6
Detachment Of Device Component 5
Other (for use when an appropriate device code cannot be identified) 5
Sticking 5
Pressure, insufficient 4
Use of Incorrect Control/Treatment Settings 4

Yearly Trend

91
1991: 2
92
1992: 24
93
1993: 10
94
1994: 6
95
1995: 2
05
2005: 1
06
2006: 1
08
2008: 2
09
2009: 3
10
2010: 5
11
2011: 15
12
2012: 62
13
2013: 16
14
2014: 5
15
2015: 1
16
2016: 1
17
2017: 3
18
2018: 4
19
2019: 2
20
2020: 1
21
2021: 9
22
2022: 4
23
2023: 51
24
2024: 133
25
2025: 46
26
2026: 12

Reports fell to 46 in 2025, down from an average of 92 in the two years before.

Related Entities for Cuff, Tracheal Tube, Inflatable

Top Manufacturers

HAMILTON MEDICAL AG 208
PLEXUS MANUFACTURING SDN. BHD. 23
TELEFLEX MEDICAL 12
COVIDIEN 6

Event Locations

352 (83.6%)
HOSPITAL 44 (10.5%)
I 16 (3.8%)
INVALID DATA 2 (0.5%)
OTHER 2 (0.5%)
UNKNOWN 2 (0.5%)
HOME 1 (0.2%)
NO INFORMATION 1 (0.2%)
NURSING HOME 1 (0.2%)

Compare HAMILTON MEDICAL AG vs PLEXUS MANUFACTURING SDN. BHD. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Cuff, Tracheal Tube, Inflatable: 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 (421 here).

Fibrin Sealant Preparation Device 419 Table, Radiologic 418 Implant, Endosseous, Orthodontic 425 System, Gastrointestinal Motility 417

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Cuff, Tracheal Tube, Inflatable 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 Cuff, Tracheal Tube, Inflatable; 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.