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2026 data FDA MAUDE openFDA FDA Class I

Catheter, Nephrostomy, General & Plastic Surgery

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4200 (General, Plastic Surgery panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Catheter LIGHT-BOOK · MAUDE

#519 of 1000 · 1,835 reports · 1992–2026

  • BOOK 1,835 reports
  • RANK #519 of 1000
  • DEATH 15 death-typed
  • INJ 731 injury-typed
  • MALF 1,084 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 435
  • PHOTO Set, Blood Transfusion

Nearest event-volume peer: Set, Blood Transfusion (1 report gap)

Catheter, Nephrostomy, General & Plastic Surgery sits #519 of 1000 among tracked device types with 1,835 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

Catheter carries 39.8% INJURY-coded reports, 9.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 39.8% corpus 30.3% · above corpus mean (+9.5 pp)
  • MALF 59.1% corpus 64.8% · below corpus mean (-5.8 pp)

Lead product-problem code Leak/Splash is 21% of coded problems · Lead manufacturer COOK INC accounts for 84% of manufacturer-tagged reports · Top event location I is 64% of location-tagged rows .

Catheter in the event-volume neighbourhood

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

reports

What this shows Catheter, Nephrostomy, General & Plastic Surgery carries 1,835 MAUDE reports, ranked #519 of 1000.

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

Event Types

Malfunction 1,084 (59.1%)
Injury 731 (39.8%)
Death 15 (0.8%)
Other 3 (0.2%)
2 (0.1%)

Patient Outcomes

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

1,056 (54.7%)
Required Intervention 621 (32.2%)
Other 110 (5.7%)
R 54 (2.8%)
O 26 (1.3%)
Hospitalization 24 (1.2%)
H 15 (0.8%)
Death 12 (0.6%)
Life Threatening 9 (0.5%)
D 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Leak/Splash 383
Material Separation 259
Difficult to Remove 210
Fluid/Blood Leak 198
Break 163
Adverse Event Without Identified Device or Use Problem 128
Detachment Of Device Component 114
Detachment of Device or Device Component 107
Difficult to Advance 36
Air Leak 33
Disconnection 28
Fitting Problem 27
Other (for use when an appropriate device code cannot be identified) 24
Material Deformation 23
Gas/Air Leak 21
Tear, Rip or Hole in Device Packaging 20
Device Dislodged or Dislocated 18
Obstruction of Flow 18
Crack 16
Component Falling 15

Yearly Trend

92
1992: 1
93
1993: 1
00
2000: 3
01
2001: 3
02
2002: 4
03
2003: 4
04
2004: 1
05
2005: 3
06
2006: 3
07
2007: 14
08
2008: 11
09
2009: 5
10
2010: 8
11
2011: 6
12
2012: 4
13
2013: 6
14
2014: 20
15
2015: 47
16
2016: 38
17
2017: 422
18
2018: 435
19
2019: 175
20
2020: 127
21
2021: 115
22
2022: 121
23
2023: 145
24
2024: 32
25
2025: 71
26
2026: 10

Reports in 2025 (71) held close to the prior two-year average of 89.

Related Entities for Catheter, Nephrostomy, General & Plastic Surgery

Top Manufacturers

COOK INC 1,442
BOSTON SCIENTIFIC CORPORATION 181
COOK, INC. 60
BOSTON SCIENTIFIC - SPENCER 16
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 13

Event Locations

I 1,178 (64.2%)
469 (25.6%)
HOSPITAL 168 (9.2%)
NO INFORMATION 15 (0.8%)
HOME 2 (0.1%)
OTHER 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare COOK INC vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter: 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 (1,835 here).

Set, Blood Transfusion 1,836 Pump 1,832 Marker, Radiographic, Implantable 1,851 Generator, Lesion, Radiofrequency 1,812

Similar death-typed counts

Nearest other device types by death-typed report count (15 here), distinct from the volume row.

Display, Cathode-Ray Tube, Medical 15 Endoscopic Tissue Approximation Device 15 Guide, Wire, Catheter, Neurovasculature 15 Infusor, Pressure, For I.V. Bags 15

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

Disclaimer: MAUDE figures for Catheter 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 Catheter; 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.