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2026 data FDA MAUDE openFDA

Catheter, Intravascular, Diagnostic

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.

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FDA MAUDE casebook

openFDA event book Catheter, Intravascular, Diagnostic MID-BOOK · MAUDE

#135 of 1000 · 19,752 reports · 1992–2026

  • BOOK 19,752 reports
  • RANK #135 of 1000
  • DEATH 444 death-typed
  • INJ 7,550 injury-typed
  • MALF 10,895 malfunction
  • SPAN 1992–2026
  • PEAK 1997: 1,187
  • PHOTO Duodenoscope And Acce…

Nearest event-volume peer: Duodenoscope And Accessories, Flexible/Rigid (138 report gap)

Catheter, Intravascular, Diagnostic sits #135 of 1000 among tracked device types with 19,752 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 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
  • INJ 38.2% corpus 30.4% · above corpus mean (+7.8 pp)
  • MALF 55.2% corpus 64.5% · below corpus mean (-9.3 pp)

Lead product-problem code Fracture is 18% of coded problems · Lead manufacturer BARD ACCESS SYSTEMS accounts for 24% of manufacturer-tagged reports · Top event location is 46% of location-tagged rows .

Catheter, Intravascular, Diagnostic in the event-volume neighbourhood

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

reports

What this shows Catheter, Intravascular, Diagnostic carries 19,752 MAUDE reports, ranked #135 of 1000.

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

Event Types

Malfunction 10,895 (55.2%)
Injury 7,550 (38.2%)
Other 630 (3.2%)
Death 444 (2.2%)
232 (1.2%)
No answer provided 1 (0.0%)

Patient Outcomes

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

9,609 (44.4%)
Required Intervention 5,732 (26.5%)
Other 2,174 (10.0%)
R 1,011 (4.7%)
Life Threatening 919 (4.2%)
Hospitalization 798 (3.7%)
Death 431 (2.0%)
L 395 (1.8%)
S 258 (1.2%)
O 138 (0.6%)
Disability 79 (0.4%)
H 68 (0.3%)
Invalid Data 13 (0.1%)
Congenital Anomaly 5 (0.0%)
D 3 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Fracture 974
Material Separation 865
Adverse Event Without Identified Device or Use Problem 666
Detachment of Device or Device Component 474
Difficult to Remove 364
Device Contamination with Chemical or Other Material 295
Break 283
Failure to Align 243
Crack 200
Retraction Problem 190
Degraded 166
Detachment Of Device Component 126
Unintended Movement 104
Material Split, Cut or Torn 95
Tear, Rip or Hole in Device Packaging 95
Difficult to Advance 93
Fluid/Blood Leak 90
Material Puncture/Hole 82
Occlusion Within Device 75
Leak/Splash 74

Yearly Trend

92
1992: 9
93
1993: 40
94
1994: 228
95
1995: 220
96
1996: 531
97
1997: 1,187
98
1998: 945
99
1999: 755
00
2000: 673
01
2001: 622
02
2002: 622
03
2003: 498
04
2004: 649
05
2005: 724
06
2006: 742
07
2007: 564
08
2008: 726
09
2009: 933
10
2010: 554
11
2011: 625
12
2012: 532
13
2013: 753
14
2014: 601
15
2015: 628
16
2016: 614
17
2017: 873
18
2018: 777
19
2019: 386
20
2020: 312
21
2021: 338
22
2022: 379
23
2023: 391
24
2024: 511
25
2025: 665
26
2026: 145

Related Entities for Catheter, Intravascular, Diagnostic

Top Manufacturers

BARD ACCESS SYSTEMS 1,654
MERIT MEDICAL SYSTEMS, INC. 1,521
CORDIS CASHEL 681
ARROW INTL., INC. 679
CORDIS CORPORATION 659
CORDIS DE MEXICO 642
COOK, INC. 510
COOK INC 446

Event Locations

8,988 (45.5%)
HOSPITAL 5,817 (29.5%)
I 3,232 (16.4%)
UNKNOWN 654 (3.3%)
HOME 311 (1.6%)
INVALID DATA 300 (1.5%)
NO INFORMATION 137 (0.7%)
OTHER 129 (0.7%)
OUTPATIENT TREATMENT FACILITY 88 (0.4%)
NOT APPLICABLE 47 (0.2%)
NURSING HOME 18 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 16 (0.1%)
AMBULATORY SURGICAL FACILITY 9 (0.0%)
DIALYSIS CENTER 3 (0.0%)
HOSPICE 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
SCHOOL 1 (0.0%)

Compare BARD ACCESS SYSTEMS vs MERIT MEDICAL SYSTEMS, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Intravascular, Diagnostic, 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 (19,752 here).

Duodenoscope And Accessories, Flexible/Rigid 19,614 Port & Catheter 20,085 System, Image Processing, Radiological 19,390 Reagents 20,135

Similar death-typed counts

Nearest other device types by death-typed report count (444 here), distinct from the volume row.

Oxygenator, Cardiopulmonary Bypass 445 Set, Administration, Intravascular 438 Electrosurgical 456 Bone Cement 465

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

Disclaimer: MAUDE figures for Catheter, Intravascular, Diagnostic 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, Intravascular, Diagnostic; 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.