What are FDA adverse event reports for Prosthesis, Tracheal, Expandable?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Prosthesis, Tracheal, Expandable, there are 2,959 total reports including 107 death reports and 1,246 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Prosthesis, Tracheal, Expandable?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Prosthesis, Tracheal, Expandable

Name: Prosthesis, Tracheal, Expandable - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

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

#397 of 1000 · 2,959 reports · 1996–2026

BOOK 2,959 reports
RANK #397 of 1000
DEATH 107 death-typed
INJ 1,246 injury-typed
MALF 1,570 malfunction
SPAN 1996–2026
PEAK 2015: 251
PHOTO Agent

Nearest event-volume peer: Agent, Injectable, Embolic (2 report gap)

Prosthesis, Tracheal, Expandable sits #397 of 1000 among tracked device types with 2,959 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 →

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 3.6% corpus 1.5% · above corpus mean (+2.1 pp)
INJ 42.1% corpus 30.4% · above corpus mean (+11.7 pp)
MALF 53.1% corpus 64.5% · below corpus mean (-11.4 pp)

Lead product-problem code Activation, Positioning or Separation Problem is 23% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - GALWAY accounts for 38% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Prosthesis

2,976
Medical Devic…

2,961
Prosthesis (this)

2,959
Agent

2,957
Test

2,947
Test

2,938

What this shows Prosthesis, Tracheal, Expandable carries 2,959 MAUDE reports, ranked #397 of 1000.

Event Types

Malfunction 1,570 (53.1%)

Injury 1,246 (42.1%)

Death 107 (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.

1,494 (49.0%)

Required Intervention 1,143 (37.5%)

Other 155 (5.1%)

Death 101 (3.3%)

R 59 (1.9%)

Hospitalization 37 (1.2%)

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%)

Yearly Trend

1996: 1

1997: 11

1998: 8

1999: 6

2000: 10

2001: 27

2002: 14

2003: 29

2004: 45

2005: 112

2006: 150

2007: 150

2008: 143

2009: 163

2010: 147

2011: 95

2012: 109

2013: 238

2014: 168

2015: 251

2016: 217

2017: 109

2018: 122

2019: 106

2020: 120

2021: 106

2022: 61

2023: 110

2024: 76

2025: 51

2026: 4

Top Manufacturers

BOSTON SCIENTIFIC - GALWAY 631

BOSTON SCIENTIFIC CORPORATION 488

ATRIUM MEDICAL CORPORATION 388

ANGIOMED GMBH & CO. MEDIZINTECHNIK KG 109

BOSTON SCIENTIFIC 59

Event Locations

1,749 (59.1%)

I 806 (27.2%)

HOSPITAL 352 (11.9%)

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 similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, Tracheal, Expandable, 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 (2,959 here).

Agent, Injectable, Embolic 2,957 Medical Device Data System 2,961 Test, Hiv Detection 2,947 Prosthesis, Elbow, Constrained, Cemented 2,976

Similar death-typed counts

Nearest other device types by death-typed report count (107 here), distinct from the volume row.

Gas-Machine, Anesthesia 107 Separator 105 Temporary Carotid Catheter For Embolic Capt… 109 Absorbable Coronary Drug-Eluting Stent 110

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.

Prosthesis, Tracheal, Expandable

Event-type mix vs corpus