PlainHospital
2026 data FDA MAUDE openFDA

Introducer, 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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Introducer, Catheter MID-BOOK · MAUDE

#86 of 1000 · 38,107 reports · 1992–2026

  • BOOK 38,107 reports
  • RANK #86 of 1000
  • DEATH 1,243 death-typed
  • INJ 12,033 injury-typed
  • MALF 24,498 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 4,594
  • PHOTO Temporary Non-Roller…

Nearest event-volume peer: Temporary Non-Roller Type Left Heart Support Blood Pump (37 report gap)

Introducer, Catheter sits #86 of 1000 among tracked device types with 38,107 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 3.3% corpus 1.5% · above corpus mean (+1.7 pp)
  • INJ 31.6% corpus 30.4% · above corpus mean (+1.1 pp)
  • MALF 64.3% corpus 64.5% · near corpus mean (-0.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 15% of coded problems · Lead manufacturer BIOSENSE WEBSTER INC accounts for 23% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Introducer, Catheter in the event-volume neighbourhood

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

reports

What this shows Introducer, Catheter carries 38,107 MAUDE reports, ranked #86 of 1000.

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

Event Types

Malfunction 24,498 (64.3%)
Injury 12,033 (31.6%)
Death 1,243 (3.3%)
Other 246 (0.6%)
85 (0.2%)
No answer provided 2 (0.0%)

Patient Outcomes

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

23,329 (56.3%)
Required Intervention 7,405 (17.9%)
Other 4,002 (9.7%)
R 1,975 (4.8%)
Hospitalization 1,549 (3.7%)
Death 1,151 (2.8%)
Life Threatening 542 (1.3%)
L 476 (1.1%)
O 428 (1.0%)
H 376 (0.9%)
D 101 (0.2%)
S 52 (0.1%)
Disability 40 (0.1%)
Congenital Anomaly 8 (0.0%)
Invalid Data 4 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 4,033
Material Separation 3,903
Fluid/Blood Leak 3,706
Break 1,833
Detachment of Device or Device Component 1,739
Gas/Air Leak 1,576
Material Split, Cut or Torn 1,325
Material Deformation 1,258
Leak/Splash 1,173
Physical Resistance/Sticking 746
Backflow 741
Difficult to Insert 727
Material Puncture/Hole 676
Patient Device Interaction Problem 672
Difficult to Advance 601
Peeled/Delaminated 540
Device-Device Incompatibility 533
Unraveled Material 525
Difficult to Remove 499
Failure to Advance 478

Yearly Trend

92
1992: 20
93
1993: 24
94
1994: 54
95
1995: 49
96
1996: 215
97
1997: 452
98
1998: 313
99
1999: 195
00
2000: 131
01
2001: 140
02
2002: 154
03
2003: 170
04
2004: 235
05
2005: 260
06
2006: 303
07
2007: 316
08
2008: 423
09
2009: 399
10
2010: 445
11
2011: 628
12
2012: 898
13
2013: 743
14
2014: 780
15
2015: 913
16
2016: 1,233
17
2017: 1,671
18
2018: 1,903
19
2019: 2,450
20
2020: 2,465
21
2021: 2,835
22
2022: 4,084
23
2023: 3,775
24
2024: 3,931
25
2025: 4,594
26
2026: 906

Related Entities for Introducer, Catheter

Top Manufacturers

BIOSENSE WEBSTER INC 5,486
ST. JUDE MEDICAL 5,138
COOK INC 3,352
EDWARDS LIFESCIENCES 2,770
TERUMO MEDICAL CORPORATION 2,059
MEDTRONIC IRELAND 1,170
ABBOTT MEDICAL 994
W. L. GORE & ASSOCIATES, INC. 965
EDWARDS LIFESCIENCES LLC 874
COOK, INC. 817

Event Locations

21,979 (57.7%)
I 11,016 (28.9%)
HOSPITAL 4,561 (12.0%)
NO INFORMATION 257 (0.7%)
INVALID DATA 96 (0.3%)
OTHER 64 (0.2%)
UNKNOWN 56 (0.1%)
OUTPATIENT TREATMENT FACILITY 25 (0.1%)
HOME 15 (0.0%)
AMBULATORY SURGICAL FACILITY 13 (0.0%)
NOT APPLICABLE 13 (0.0%)
CATHETERIZATION SUITE 5 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.0%)
CATHETERIZATION LAB - FREE STANDING 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare BIOSENSE WEBSTER INC vs ST. JUDE MEDICAL →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Introducer, 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 (38,107 here).

Temporary Non-Roller Type Left Heart Suppor… 38,070 Filter, Intravascular, Cardiovascular 38,166 Plate, Fixation, Bone 37,887 Insulin Pump Secondary Display 37,844

Similar death-typed counts

Nearest other device types by death-typed report count (1,243 here), distinct from the volume row.

Automated Insulin Dosing Device System 1,227 Replacement Heart-Valve 1,324 Leadless Pacemaker 1,149 Staple, Implantable 1,085

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

Disclaimer: MAUDE figures for Introducer, 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 Introducer, 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.