2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Tubes, Gastrointestinal MID-BOOK · MAUDE

#118 of 1000 · 25,062 reports · 1992–2026

  • BOOK 25,062 reports
  • RANK #118 of 1000
  • DEATH 620 death-typed
  • INJ 12,459 injury-typed
  • MALF 11,573 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 1,901
  • PHOTO Shunt

Nearest event-volume peer: Shunt, Central Nervous System And Components (156 report gap)

Tubes, Gastrointestinal (And Accessories) sits #118 of 1000 among tracked device types with 25,062 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 →

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 2.5% corpus 1.5% · above corpus mean (+1.0 pp)
  • INJ 49.7% corpus 30.4% · above corpus mean (+19.3 pp)
  • MALF 46.2% corpus 64.5% · below corpus mean (-18.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 50% of coded problems · Lead manufacturer ABBVIE - MEDICAL DEVICE CENTER accounts for 43% of manufacturer-tagged reports · Top event location is 49% 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 25,062 MAUDE reports, ranked #118 of 1000.

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

Event Types

Injury 12,459 (49.7%)
Malfunction 11,573 (46.2%)
Death 620 (2.5%)
Other 254 (1.0%)
156 (0.6%)

Patient Outcomes

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

10,114 (36.6%)
Required Intervention 8,997 (32.5%)
Other 3,329 (12.0%)
Hospitalization 1,929 (7.0%)
R 1,795 (6.5%)
Death 473 (1.7%)
H 402 (1.5%)
O 238 (0.9%)
Life Threatening 162 (0.6%)
L 117 (0.4%)
D 30 (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 7,585
Break 1,054
Fluid/Blood Leak 963
Detachment of Device or Device Component 724
Insufficient Information 689
Leak/Splash 616
Malposition of Device 394
Difficult to Remove 380
Material Rupture 351
Obstruction of Flow 332
Device Dislodged or Dislocated 249
Material Puncture/Hole 242
Detachment Of Device Component 225
Material Split, Cut or Torn 219
Unintended Deflation 219
Deflation Problem 214
Disconnection 212
Occlusion Within Device 179
Material Twisted/Bent 171
Material Separation 152

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: 265

Related Entities for Tubes, Gastrointestinal (And Accessories)

Event Locations

12,310 (49.1%)
I 9,237 (36.9%)
HOSPITAL 2,800 (11.2%)
NO INFORMATION 319 (1.3%)
HOME 109 (0.4%)
INVALID DATA 70 (0.3%)
OTHER 70 (0.3%)
NURSING HOME 43 (0.2%)
OUTPATIENT TREATMENT FACILITY 38 (0.2%)
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 BOSTON SCIENTIFIC - SPENCER →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Tubes, Gastrointestinal, 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 (25,062 here).

Similar death-typed counts

Nearest other device types by death-typed report count (620 here), distinct from the volume row.

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.