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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.1200 (Cardiovascular panel).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#140 of 1000 · 20,128 reports · 1992–2026

  • BOOK 20,128 reports
  • RANK #140 of 1000
  • DEATH 445 death-typed
  • INJ 7,584 injury-typed
  • MALF 11,236 malfunction
  • SPAN 1992–2026
  • PEAK 1997: 1,187
  • PHOTO Reagents

Nearest event-volume peer: Reagents, 2019-Novel Coronavirus Nucleic Acid (14 report gap)

Catheter, Intravascular, Diagnostic sits #140 of 1000 among tracked device types with 20,128 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 →

Malfunction reports sit below the device-type norm

Catheter, Intravascular, Diagnostic carries 55.8% MALFUNCTION-coded reports, 9.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
  • INJ 37.7% corpus 30.3% · above corpus mean (+7.4 pp)
  • MALF 55.8% corpus 64.8% · below corpus mean (-9.0 pp)

Lead product-problem code Break is 14% 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 20,128 MAUDE reports, ranked #140 of 1000.

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

Event Types

Malfunction 11,236 (55.8%)
Injury 7,584 (37.7%)
Other 630 (3.1%)
Death 445 (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.

9,877 (44.9%)
Required Intervention 5,753 (26.2%)
Other 2,224 (10.1%)
R 1,016 (4.6%)
Life Threatening 921 (4.2%)
Hospitalization 800 (3.6%)
Death 431 (2.0%)
L 400 (1.8%)
S 258 (1.2%)
O 148 (0.7%)
Disability 80 (0.4%)
H 69 (0.3%)
Invalid Data 13 (0.1%)
Congenital Anomaly 5 (0.0%)
D 4 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Break 2,791
Material Separation 1,963
Difficult to Remove 1,742
Fracture 1,578
Leak/Splash 1,256
Implant, removal of 1,183
Replace 1,111
Explanted 970
Adverse Event Without Identified Device or Use Problem 843
Detachment Of Device Component 773
Retraction Problem 725
Difficult to Insert 713
Tip breakage 679
Crack 666
Migration or Expulsion of Device 638
Device, removal of (non-implant) 629
Detachment of Device or Device Component 596
Device Contamination with Chemical or Other Material 576
Unknown (for use when the device problem is not known) 551
Fluid/Blood Leak 502

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: 521

Reports rose to 665 in 2025, up from an average of 451 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Intravascular, Diagnostic

Top Manufacturers

BARD ACCESS SYSTEMS 1,654
MERIT MEDICAL SYSTEMS, INC. 1,550
CORDIS CASHEL 681
ARROW INTL., INC. 679
CORDIS CORPORATION 660
CORDIS DE MEXICO 642
COOK, INC. 510
COOK INC 453

Event Locations

9,330 (46.4%)
HOSPITAL 5,851 (29.1%)
I 3,232 (16.1%)
UNKNOWN 654 (3.2%)
HOME 311 (1.5%)
INVALID DATA 300 (1.5%)
NO INFORMATION 137 (0.7%)
OTHER 129 (0.6%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Intravascular, Diagnostic: 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 (20,128 here).

Reagents 20,142 Suture 20,010 Leadless Pacemaker 19,964 Orthopedic Stereotaxic Instrument 20,328

Similar death-typed counts

Nearest other device types by death-typed report count (445 here), distinct from the volume row.

Oxygenator, Cardiopulmonary Bypass 449 Electrosurgical 467 Lift, Patient, Non-Ac-Powered 423 Bone Cement 469

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.