What are FDA adverse event reports for Prosthesis, Esophageal?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Prosthesis, Esophageal, there are 3,051 total reports including 130 death reports and 1,421 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, Esophageal?

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, Esophageal

Name: Prosthesis, Esophageal - 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, Esophageal LIGHT-BOOK · MAUDE

#388 of 1000 · 3,051 reports · 1995–2026

BOOK 3,051 reports
RANK #388 of 1000
DEATH 130 death-typed
INJ 1,421 injury-typed
MALF 1,482 malfunction
SPAN 1995–2026
PEAK 2010: 255
PHOTO Saline

Nearest event-volume peer: Saline, Vascular Access Flush (0 report gap)

Prosthesis, Esophageal sits #388 of 1000 among tracked device types with 3,051 MAUDE reports spanning 1995–2026. 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 4.3% corpus 1.5% · above corpus mean (+2.7 pp)
INJ 46.6% corpus 30.4% · above corpus mean (+16.1 pp)
MALF 48.6% corpus 64.5% · below corpus mean (-15.9 pp)

Lead product-problem code Activation, Positioning or Separation Problem is 18% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - GALWAY accounts for 42% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Stimulator

3,075
Ventilator

3,062
Accelerator

3,052
Prosthesis (this)

3,051
Saline

3,051
Active Implan…

3,021

What this shows Prosthesis, Esophageal carries 3,051 MAUDE reports, ranked #388 of 1000.

Event Types

Malfunction 1,482 (48.6%)

Injury 1,421 (46.6%)

Death 130 (4.3%)

Other 12 (0.4%)

6 (0.2%)

Patient Outcomes

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

1,408 (43.9%)

Required Intervention 1,234 (38.5%)

Hospitalization 138 (4.3%)

Death 134 (4.2%)

R 120 (3.7%)

Other 115 (3.6%)

H 16 (0.5%)

Life Threatening 16 (0.5%)

O 9 (0.3%)

L 7 (0.2%)

D 4 (0.1%)

Disability 4 (0.1%)

S 3 (0.1%)

Congenital Anomaly 1 (0.0%)

Yearly Trend

1995: 1

1996: 6

1997: 31

1998: 28

1999: 27

2000: 11

2001: 11

2002: 11

2003: 20

2004: 32

2005: 29

2006: 71

2007: 88

2008: 153

2009: 237

2010: 255

2011: 140

2012: 121

2013: 143

2014: 169

2015: 175

2016: 153

2017: 87

2018: 86

2019: 167

2020: 155

2021: 77

2022: 109

2023: 155

2024: 166

2025: 122

2026: 15

Top Manufacturers

BOSTON SCIENTIFIC - GALWAY 983

BOSTON SCIENTIFIC CORPORATION 734

COOK IRELAND LTD 382

BOSTON SCIENTIFIC 89

MERIT MEDICAL SYSTEMS, INC. 54

BOSTON SCIENTIFIC - MARLBOROUGH 48

BOSTON SCIENTIFIC CORP 37

Event Locations

1,838 (60.2%)

I 607 (19.9%)

HOSPITAL 547 (17.9%)

NOT APPLICABLE 31 (1.0%)

NO INFORMATION 10 (0.3%)

HOME 4 (0.1%)

INVALID DATA 4 (0.1%)

UNKNOWN 4 (0.1%)

OUTPATIENT DIAGNOSTIC FACILITY 3 (0.1%)

OTHER 2 (0.1%)

AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare BOSTON SCIENTIFIC - GALWAY vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, Esophageal, 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 (3,051 here).

Saline, Vascular Access Flush 3,051 Accelerator, Linear, Medical 3,052 Ventilator, High Frequency 3,062 Stimulator 3,075

Similar death-typed counts

Nearest other device types by death-typed report count (130 here), distinct from the volume row.

Catheter, Peripheral, Atherectomy 126 Peripheral Mechanical Thrombectomy With Asp… 126 Transcervical Contraceptive Tubal Occlusion… 134 Catheter 125

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

Disclaimer: MAUDE figures for Prosthesis, Esophageal 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, Esophageal; 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, Esophageal

Event-type mix vs corpus