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2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Tracheal, Expandable

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 §878.3720 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Prosthesis, Tracheal, Expandable LIGHT-BOOK · MAUDE

#408 of 1000 · 3,009 reports · 1996–2026

  • BOOK 3,009 reports
  • RANK #408 of 1000
  • DEATH 108 death-typed
  • INJ 1,273 injury-typed
  • MALF 1,592 malfunction
  • SPAN 1996–2026
  • PEAK 2015: 251
  • PHOTO Interoperable Automat…

Nearest event-volume peer: Interoperable Automated Glycemic Controller (0 report gap)

Prosthesis, Tracheal, Expandable sits #408 of 1000 among tracked device types with 3,009 MAUDE reports spanning 1996–2026. 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 run above the device-type norm

Prosthesis, Tracheal, Expandable carries 42.3% INJURY-coded reports, 12.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.6% corpus 1.5% · above corpus mean (+2.1 pp)
  • INJ 42.3% corpus 30.3% · above corpus mean (+12.0 pp)
  • MALF 52.9% corpus 64.8% · below corpus mean (-11.9 pp)

Lead product-problem code Activation, Positioning or Separation Problem is 14% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - GALWAY accounts for 37% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Prosthesis, Tracheal, Expandable in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Tracheal, Expandable carries 3,009 MAUDE reports, ranked #408 of 1000.

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

Event Types

Malfunction 1,592 (52.9%)
Injury 1,273 (42.3%)
Death 108 (3.6%)
Other 23 (0.8%)
13 (0.4%)

Patient Outcomes

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

1,514 (49.0%)
Required Intervention 1,147 (37.1%)
Other 156 (5.1%)
Death 101 (3.3%)
R 59 (1.9%)
Hospitalization 51 (1.7%)
Life Threatening 24 (0.8%)
L 9 (0.3%)
S 9 (0.3%)
O 7 (0.2%)
Disability 5 (0.2%)
D 3 (0.1%)
H 3 (0.1%)

Top Product Problems

Activation, Positioning or Separation Problem 419
Positioning Failure 406
Break 235
Fracture 181
Adverse Event Without Identified Device or Use Problem 169
Positioning Problem 166
Detachment Of Device Component 161
Difficult to Remove 140
Replace 139
Material Deformation 126
Activation Failure 121
Appropriate Device Problem Term/Code Not Available 120
Migration or Expulsion of Device 118
Difficult or Delayed Positioning 115
Device Dislodged or Dislocated 101
Device remains implanted 72
Failure to Advance 71
Material Separation 71
Sticking 69
Explanted 67

Yearly Trend

96
1996: 1
97
1997: 11
98
1998: 8
99
1999: 6
00
2000: 10
01
2001: 27
02
2002: 14
03
2003: 29
04
2004: 45
05
2005: 112
06
2006: 150
07
2007: 150
08
2008: 143
09
2009: 163
10
2010: 147
11
2011: 95
12
2012: 109
13
2013: 238
14
2014: 168
15
2015: 251
16
2016: 217
17
2017: 109
18
2018: 122
19
2019: 106
20
2020: 120
21
2021: 106
22
2022: 61
23
2023: 110
24
2024: 76
25
2025: 50
26
2026: 55

Reports fell to 50 in 2025, down from an average of 93 in the two years before.

Related Entities for Prosthesis, Tracheal, Expandable

Top Manufacturers

BOSTON SCIENTIFIC - GALWAY 631
BOSTON SCIENTIFIC CORPORATION 526
ATRIUM MEDICAL CORPORATION 388
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG 109
BOSTON SCIENTIFIC 59

Event Locations

1,799 (59.8%)
I 806 (26.8%)
HOSPITAL 352 (11.7%)
NOT APPLICABLE 22 (0.7%)
NO INFORMATION 16 (0.5%)
OTHER 5 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.1%)
HOME 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
INVALID DATA 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare BOSTON SCIENTIFIC - GALWAY vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Tracheal, Expandable: 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 (3,009 here).

Interoperable Automated Glycemic Controller 3,009 Latex Patient Examination Glove 2,992 Medical Device Data System 2,981 System, Photopheresis, Extracorporeal 2,966

Similar death-typed counts

Nearest other device types by death-typed report count (108 here), distinct from the volume row.

Stretcher, Wheeled 108 Powered Laser Surgical Instrument 107 Absorbable Coronary Drug-Eluting Stent 110 Separator 106

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

Disclaimer: MAUDE figures for Prosthesis, Tracheal, Expandable 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 Prosthesis, Tracheal, Expandable; 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.