2026 data FDA MAUDE openFDA FDA Class II

Catheter, Umbilical Artery

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 §880.5200 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Catheter, Umbilical Artery LIGHT-BOOK · MAUDE

#561 of 1000 · 1,545 reports · 1992–2026

  • BOOK 1,545 reports
  • RANK #561 of 1000
  • DEATH 33 death-typed
  • INJ 249 injury-typed
  • MALF 1,184 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 139
  • PHOTO Toothbrush, Manual

Nearest event-volume peer: Toothbrush, Manual (1 report gap)

Catheter, Umbilical Artery sits #561 of 1000 among tracked device types with 1,545 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 sit below the device-type norm

Catheter, Umbilical Artery carries 16.1% INJURY-coded reports, 14.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
  • INJ 16.1% corpus 30.3% · below corpus mean (-14.2 pp)
  • MALF 76.6% corpus 64.8% · above corpus mean (+11.8 pp)

Lead product-problem code Leak/Splash is 29% of coded problems · Lead manufacturer COVIDIEN accounts for 90% of manufacturer-tagged reports · Top event location HOSPITAL is 45% of location-tagged rows .

Catheter, Umbilical Artery in the event-volume neighbourhood

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

reports

What this shows Catheter, Umbilical Artery carries 1,545 MAUDE reports, ranked #561 of 1000.

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

Event Types

Malfunction 1,184 (76.6%)
Injury 249 (16.1%)
Other 45 (2.9%)
34 (2.2%)
Death 33 (2.1%)

Patient Outcomes

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

1,165 (74.0%)
Required Intervention 177 (11.2%)
Other 118 (7.5%)
Death 35 (2.2%)
R 23 (1.5%)
Life Threatening 16 (1.0%)
Hospitalization 15 (1.0%)
Disability 9 (0.6%)
O 5 (0.3%)
Invalid Data 5 (0.3%)
S 3 (0.2%)
L 2 (0.1%)
D 1 (0.1%)
H 1 (0.1%)

Top Product Problems

Leak/Splash 474
Break 344
Fluid/Blood Leak 261
Crack 140
Difficult to Remove 62
Hole In Material 37
Connection Problem 32
Replace 32
Device, removal of (non-implant) 31
Material Separation 26
Implant, removal of 23
Fracture 22
Detachment Of Device Component 21
Material Fragmentation 21
Unknown (for use when the device problem is not known) 21
Air Leak 19
Migration or Expulsion of Device 18
Malposition of Device 17
Other (for use when an appropriate device code cannot be identified) 17
Component(s), broken 16

Yearly Trend

92
1992: 7
93
1993: 5
94
1994: 18
95
1995: 7
96
1996: 17
97
1997: 45
98
1998: 33
99
1999: 21
00
2000: 21
01
2001: 16
02
2002: 4
03
2003: 14
04
2004: 15
05
2005: 20
06
2006: 38
07
2007: 26
08
2008: 42
09
2009: 40
10
2010: 94
11
2011: 74
12
2012: 70
13
2013: 95
14
2014: 69
15
2015: 81
16
2016: 115
17
2017: 139
18
2018: 84
19
2019: 64
20
2020: 43
21
2021: 49
22
2022: 38
23
2023: 20
24
2024: 52
25
2025: 56
26
2026: 13

Reports rose to 56 in 2025, up from an average of 36 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Umbilical Artery

Top Manufacturers

Event Locations

HOSPITAL 701 (45.4%)
I 420 (27.2%)
371 (24.0%)
NO INFORMATION 24 (1.6%)
INVALID DATA 15 (1.0%)
NOT APPLICABLE 7 (0.5%)
OTHER 4 (0.3%)
UNKNOWN 2 (0.1%)
HOME 1 (0.1%)

Compare COVIDIEN vs CARDINAL HEALTH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Umbilical Artery: 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 (1,545 here).

Similar death-typed counts

Nearest other device types by death-typed report count (33 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Umbilical Artery 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, Umbilical Artery; 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.