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2026 data FDA MAUDE openFDA FDA Class II

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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 §880.5970 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Catheter MID-BOOK · MAUDE

#95 of 1000 · 36,803 reports · 1992–2026

  • BOOK 36,803 reports
  • RANK #95 of 1000
  • DEATH 128 death-typed
  • INJ 6,194 injury-typed
  • MALF 29,839 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 4,424
  • PHOTO Replacement Heart-Val…

Nearest event-volume peer: Replacement Heart-Valve (297 report gap)

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days sits #95 of 1000 among tracked device types with 36,803 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 run above the device-type norm

Catheter carries 81.1% MALFUNCTION-coded reports, 16.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 16.8% corpus 30.3% · below corpus mean (-13.5 pp)
  • MALF 81.1% corpus 64.8% · above corpus mean (+16.3 pp)

Lead product-problem code Fluid/Blood Leak is 33% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 61% of manufacturer-tagged reports · Top event location is 54% 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days carries 36,803 MAUDE reports, ranked #95 of 1000.

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

Event Types

Malfunction 29,839 (81.1%)
Injury 6,194 (16.8%)
Other 491 (1.3%)
150 (0.4%)
Death 128 (0.3%)
No answer provided 1 (0.0%)

Patient Outcomes

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

Other 14,575 (39.2%)
14,331 (38.5%)
Required Intervention 7,119 (19.1%)
Hospitalization 354 (1.0%)
R 297 (0.8%)
Death 131 (0.4%)
Disability 122 (0.3%)
O 119 (0.3%)
Life Threatening 61 (0.2%)
L 36 (0.1%)
S 21 (0.1%)
H 10 (0.0%)
D 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 11,048
Break 4,227
Material Deformation 2,505
Leak/Splash 2,309
Fracture 1,715
Crack 1,273
Adverse Event Without Identified Device or Use Problem 1,262
Defective Component 1,119
Material Frayed 905
Material Separation 858
Detachment Of Device Component 734
Hole In Material 691
Difficult to Remove 677
Component Incompatible 670
Detachment of Device or Device Component 606
Failure to Infuse 562
Contamination /Decontamination Problem 514
Migration or Expulsion of Device 472
Material Puncture/Hole 470
Device Dislodged or Dislocated 441

Yearly Trend

92
1992: 2
93
1993: 1
95
1995: 1
96
1996: 4
97
1997: 29
98
1998: 15
99
1999: 23
00
2000: 25
01
2001: 11
02
2002: 50
03
2003: 66
04
2004: 277
05
2005: 265
06
2006: 477
07
2007: 392
08
2008: 369
09
2009: 379
10
2010: 494
11
2011: 696
12
2012: 564
13
2013: 680
14
2014: 842
15
2015: 1,306
16
2016: 1,123
17
2017: 2,100
18
2018: 2,324
19
2019: 2,052
20
2020: 2,539
21
2021: 3,084
22
2022: 3,256
23
2023: 2,799
24
2024: 4,243
25
2025: 4,424
26
2026: 1,891

Reports in 2025 (4,424) held close to the prior two-year average of 3,521.

Related Entities for Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Top Manufacturers

C.R. BARD, INC. (BASD) -3006260740 16,580
BARD ACCESS SYSTEMS 7,400
ARROW INTERNATIONAL INC. 1,266
ARROW INTERNATIONAL LLC 928
COOK INC 809

Event Locations

19,953 (54.2%)
HOSPITAL 9,638 (26.2%)
I 6,466 (17.6%)
NO INFORMATION 375 (1.0%)
HOME 158 (0.4%)
OTHER 76 (0.2%)
UNKNOWN 58 (0.2%)
OUTPATIENT TREATMENT FACILITY 27 (0.1%)
NOT APPLICABLE 18 (0.0%)
NURSING HOME 11 (0.0%)
INVALID DATA 6 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.0%)
CHEMOTHERAPY CENTER 3 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
HOSPICE 2 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)
EMERGENCY ROOM 1 (0.0%)
EXAMINATION ROOM 1 (0.0%)
REHABILITATION CENTER 1 (0.0%)
TUBERCULOSIS CLINIC 1 (0.0%)

Compare C.R. BARD, INC. (BASD) -3006260740 vs BARD ACCESS SYSTEMS →

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 (36,803 here).

Replacement Heart-Valve 37,100 Rod 37,471 Hexokinase, Glucose 37,534 Catheter 35,724

Similar death-typed counts

Nearest other device types by death-typed report count (128 here), distinct from the volume row.

Peripheral Mechanical Thrombectomy With Asp… 128 Clip, Implantable 126 Endovascular Suturing System 126 Humidifier, Respiratory Gas, 126

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.