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2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Esophageal

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 §878.3610 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Prosthesis, Esophageal LIGHT-BOOK · MAUDE

#401 of 1000 · 3,094 reports · 1995–2026

  • BOOK 3,094 reports
  • RANK #401 of 1000
  • DEATH 130 death-typed
  • INJ 1,432 injury-typed
  • MALF 1,514 malfunction
  • SPAN 1995–2026
  • PEAK 2010: 255
  • PHOTO Joint

Nearest event-volume peer: Joint, Temporomandibular, Implant (2 report gap)

Prosthesis, Esophageal sits #401 of 1000 among tracked device types with 3,094 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 →

Injury-coded reports run above the device-type norm

Prosthesis, Esophageal carries 46.3% INJURY-coded reports, 16.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.2% corpus 1.5% · above corpus mean (+2.7 pp)
  • INJ 46.3% corpus 30.3% · above corpus mean (+16.0 pp)
  • MALF 48.9% corpus 64.8% · below corpus mean (-15.9 pp)

Lead product-problem code Activation, Positioning or Separation Problem is 16% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - GALWAY accounts for 42% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Prosthesis, Esophageal in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Esophageal carries 3,094 MAUDE reports, ranked #401 of 1000.

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

Event Types

Malfunction 1,514 (48.9%)
Injury 1,432 (46.3%)
Death 130 (4.2%)
Other 12 (0.4%)
6 (0.2%)

Patient Outcomes

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

1,432 (44.1%)
Required Intervention 1,246 (38.3%)
Hospitalization 139 (4.3%)
Death 134 (4.1%)
R 120 (3.7%)
Other 116 (3.6%)
H 16 (0.5%)
Life Threatening 16 (0.5%)
O 12 (0.4%)
L 7 (0.2%)
D 4 (0.1%)
Disability 4 (0.1%)
S 3 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Activation, Positioning or Separation Problem 564
Migration or Expulsion of Device 412
Activation Failure 256
Break 252
Adverse Event Without Identified Device or Use Problem 207
Positioning Failure 203
Migration 184
Positioning Problem 175
Difficult to Remove 164
Appropriate Device Problem Term/Code Not Available 128
Other (for use when an appropriate device code cannot be identified) 111
Material Deformation 105
Use of Device Problem 97
Detachment of Device or Device Component 95
Material Integrity Problem 92
Partial Blockage 90
Activation Problem 80
Fracture 77
Replace 77
Improper or Incorrect Procedure or Method 64

Yearly Trend

95
1995: 1
96
1996: 6
97
1997: 31
98
1998: 28
99
1999: 27
00
2000: 11
01
2001: 11
02
2002: 11
03
2003: 20
04
2004: 32
05
2005: 29
06
2006: 71
07
2007: 88
08
2008: 153
09
2009: 237
10
2010: 255
11
2011: 140
12
2012: 121
13
2013: 143
14
2014: 169
15
2015: 175
16
2016: 153
17
2017: 87
18
2018: 86
19
2019: 167
20
2020: 155
21
2021: 77
22
2022: 109
23
2023: 155
24
2024: 165
25
2025: 122
26
2026: 59

Reports in 2025 (122) held close to the prior two-year average of 160.

Related Entities for Prosthesis, Esophageal

Top Manufacturers

BOSTON SCIENTIFIC - GALWAY 983
BOSTON SCIENTIFIC CORPORATION 752
COOK IRELAND LTD 387
BOSTON SCIENTIFIC 89
MERIT MEDICAL SYSTEMS, INC. 64
BOSTON SCIENTIFIC - MARLBOROUGH 48
BOSTON SCIENTIFIC CORP 37

Event Locations

1,871 (60.5%)
I 607 (19.6%)
HOSPITAL 557 (18.0%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Esophageal: 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 (3,094 here).

Joint, Temporomandibular, Implant 3,096 Ventilator, High Frequency 3,097 Test, Hepatitis B 3,089 Monitor, Cardiac 3,110

Similar death-typed counts

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

Catheter 128 Peripheral Mechanical Thrombectomy With Asp… 128 Clip, Implantable 126 Endovascular Suturing System 126

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.