2026 data FDA MAUDE openFDA

Accessories, Catheter

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 Accessories, Catheter LIGHT-BOOK · MAUDE

#689 of 1000 · 859 reports · 1992–2026

  • BOOK 859 reports
  • RANK #689 of 1000
  • DEATH 10 death-typed
  • INJ 118 injury-typed
  • MALF 727 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 113
  • PHOTO Stent, Renal

Nearest event-volume peer: Stent, Renal (2 report gap)

Accessories, Catheter sits #689 of 1000 among tracked device types with 859 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 1.2% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 13.7% corpus 30.4% · below corpus mean (-16.7 pp)
  • MALF 84.6% corpus 64.5% · above corpus mean (+20.1 pp)

Lead product-problem code Leak/Splash is 17% of coded problems · Lead manufacturer COOK INC accounts for 55% of manufacturer-tagged reports · Top event location I is 48% of location-tagged rows .

Accessories, Catheter in the event-volume neighbourhood

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

reports

What this shows Accessories, Catheter carries 859 MAUDE reports, ranked #689 of 1000.

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

Event Types

Malfunction 727 (84.6%)
Injury 118 (13.7%)
Death 10 (1.2%)
2 (0.2%)
Other 2 (0.2%)

Patient Outcomes

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

703 (80.7%)
Required Intervention 67 (7.7%)
Other 61 (7.0%)
Death 10 (1.1%)
Hospitalization 10 (1.1%)
R 9 (1.0%)
Life Threatening 6 (0.7%)
O 5 (0.6%)

Top Product Problems

Leak/Splash 115
Fluid/Blood Leak 97
Loss of or Failure to Bond 85
Break 59
Migration or Expulsion of Device 50
Material Separation 48
Unraveled Material 37
Detachment of Device or Device Component 29
Crack 27
Defective Device 22
Difficult to Remove 21
Failure To Adhere Or Bond 19
Fracture 16
Adverse Event Without Identified Device or Use Problem 10
Device Operates Differently Than Expected 10
Unsealed Device Packaging 10
Degraded 6
Device Contaminated During Manufacture or Shipping 6
Difficult to Advance 6
Detachment Of Device Component 5

Yearly Trend

92
1992: 1
93
1993: 2
94
1994: 1
95
1995: 1
96
1996: 4
97
1997: 6
98
1998: 1
99
1999: 1
00
2000: 1
01
2001: 3
02
2002: 4
03
2003: 6
04
2004: 5
05
2005: 3
06
2006: 5
07
2007: 1
08
2008: 3
09
2009: 7
10
2010: 37
11
2011: 36
12
2012: 17
13
2013: 16
14
2014: 6
15
2015: 20
16
2016: 54
17
2017: 78
18
2018: 100
19
2019: 66
20
2020: 113
21
2021: 36
22
2022: 88
23
2023: 55
24
2024: 44
25
2025: 31
26
2026: 7

Related Entities for Accessories, Catheter

Event Locations

I 415 (48.3%)
372 (43.3%)
HOSPITAL 54 (6.3%)
NO INFORMATION 9 (1.0%)
INVALID DATA 5 (0.6%)
HOME 2 (0.2%)
OTHER 2 (0.2%)

Compare COOK INC vs B. BRAUN MEDICAL INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Accessories, Catheter, 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 (859 here).

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Disclaimer: MAUDE figures for Accessories, 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 Accessories, 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.