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2026 data FDA MAUDE openFDA FDA Class II

Tubes, Gastrointestinal (And Accessories)

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 §876.5980 (Gastroenterology, Urology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Tubes, Gastrointestinal MID-BOOK · MAUDE

#118 of 1000 · 26,072 reports · 1992–2026

  • BOOK 26,072 reports
  • RANK #118 of 1000
  • DEATH 630 death-typed
  • INJ 12,781 injury-typed
  • MALF 12,248 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 1,901
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (121 report gap)

Tubes, Gastrointestinal (And Accessories) sits #118 of 1000 among tracked device types with 26,072 MAUDE reports spanning 1992–2026. 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

Tubes, Gastrointestinal carries 49.0% INJURY-coded reports, 18.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.4% corpus 1.5% · above corpus mean (+0.9 pp)
  • INJ 49.0% corpus 30.3% · above corpus mean (+18.7 pp)
  • MALF 47.0% corpus 64.8% · below corpus mean (-17.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 37% of coded problems · Lead manufacturer ABBVIE - MEDICAL DEVICE CENTER accounts for 42% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Tubes, Gastrointestinal in the event-volume neighbourhood

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

reports

What this shows Tubes, Gastrointestinal (And Accessories) carries 26,072 MAUDE reports, ranked #118 of 1000.

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

Event Types

Injury 12,781 (49.0%)
Malfunction 12,248 (47.0%)
Death 630 (2.4%)
Other 257 (1.0%)
156 (0.6%)

Patient Outcomes

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

10,649 (37.2%)
Required Intervention 9,177 (32.1%)
Other 3,466 (12.1%)
Hospitalization 1,973 (6.9%)
R 1,825 (6.4%)
Death 476 (1.7%)
H 429 (1.5%)
O 245 (0.9%)
Life Threatening 164 (0.6%)
L 120 (0.4%)
D 35 (0.1%)
Disability 29 (0.1%)
S 24 (0.1%)
Congenital Anomaly 4 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 8,136
Break 1,955
Leak/Splash 1,228
Detachment Of Device Component 1,207
Fluid/Blood Leak 1,179
Difficult to Remove 1,041
Insufficient Device Problem Information 964
Detachment of Device or Device Component 799
Occlusion Within Device 608
Deflation Problem 522
Malposition of Device 520
Material Rupture 520
Migration or Expulsion of Device 507
Material Separation 455
Replace 439
Obstruction of Flow 370
Device Dislodged or Dislocated 361
Material Puncture/Hole 352
Inflation Problem 342
Device, removal of (non-implant) 310

Yearly Trend

92
1992: 6
93
1993: 4
94
1994: 25
95
1995: 55
96
1996: 119
97
1997: 167
98
1998: 151
99
1999: 136
00
2000: 128
01
2001: 103
02
2002: 91
03
2003: 138
04
2004: 210
05
2005: 248
06
2006: 311
07
2007: 300
08
2008: 867
09
2009: 818
10
2010: 517
11
2011: 531
12
2012: 528
13
2013: 747
14
2014: 1,030
15
2015: 1,048
16
2016: 1,251
17
2017: 1,672
18
2018: 1,901
19
2019: 1,838
20
2020: 1,641
21
2021: 1,655
22
2022: 1,650
23
2023: 1,863
24
2024: 1,577
25
2025: 1,471
26
2026: 1,275

Reports in 2025 (1,471) held close to the prior two-year average of 1,720.

Related Entities for Tubes, Gastrointestinal (And Accessories)

Top Manufacturers

ABBVIE - MEDICAL DEVICE CENTER 6,457
AVANOS MEDICAL INC. 2,257
BOSTON SCIENTIFIC - SPENCER 1,781
COVIDIEN 1,512
BOSTON SCIENTIFIC CORPORATION 1,333
C.R. BARD, INC. (COVINGTON) -1018233 759
CARDINAL HEALTH 753
BARD ACCESS SYSTEMS 492

Event Locations

13,298 (51.0%)
I 9,237 (35.4%)
HOSPITAL 2,821 (10.8%)
NO INFORMATION 319 (1.2%)
HOME 110 (0.4%)
INVALID DATA 70 (0.3%)
OTHER 70 (0.3%)
NURSING HOME 43 (0.2%)
OUTPATIENT TREATMENT FACILITY 38 (0.1%)
UNKNOWN 32 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 18 (0.1%)
NOT APPLICABLE 7 (0.0%)
AMBULATORY SURGICAL FACILITY 5 (0.0%)
RETIREMENT HOME 3 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)

Compare ABBVIE - MEDICAL DEVICE CENTER vs AVANOS MEDICAL INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tubes, Gastrointestinal: 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 (26,072 here).

Prosthesis 25,951 Device, Neurovascular Embolization 26,211 Wheelchair, Mechanical 26,370 Fastener 25,623

Similar death-typed counts

Nearest other device types by death-typed report count (630 here), distinct from the volume row.

Intracranial Aneurysm Flow Diverter 616 Bed, Ac-Powered Adjustable Hospital 647 Catheters 583 Monitor, Cardiac 575

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

Disclaimer: MAUDE figures for Tubes, Gastrointestinal 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 Tubes, Gastrointestinal; 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.