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2026 data FDA MAUDE openFDA

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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 LIGHT-BOOK · MAUDE

#287 of 1000 · 5,758 reports · 1992–2026

  • BOOK 5,758 reports
  • RANK #287 of 1000
  • DEATH 288 death-typed
  • INJ 1,204 injury-typed
  • MALF 4,117 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,030
  • PHOTO Holder

Nearest event-volume peer: Holder, Head, Neurosurgical (Skull Clamp) (6 report gap)

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass sits #287 of 1000 among tracked device types with 5,758 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 5.0% corpus 1.5% · above corpus mean (+3.5 pp)
  • INJ 20.9% corpus 30.4% · below corpus mean (-9.5 pp)
  • MALF 71.5% corpus 64.5% · above corpus mean (+7.0 pp)

Lead product-problem code Material Separation is 16% of coded problems · Lead manufacturer PERFUSION SYSTEMS accounts for 38% of manufacturer-tagged reports · Top event location is 58% 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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass carries 5,758 MAUDE reports, ranked #287 of 1000.

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

Event Types

Malfunction 4,117 (71.5%)
Injury 1,204 (20.9%)
Death 288 (5.0%)
Other 76 (1.3%)
73 (1.3%)

Patient Outcomes

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

3,870 (63.2%)
Required Intervention 840 (13.7%)
Other 490 (8.0%)
Death 275 (4.5%)
R 217 (3.5%)
Life Threatening 142 (2.3%)
Hospitalization 128 (2.1%)
L 72 (1.2%)
H 33 (0.5%)
O 28 (0.5%)
S 12 (0.2%)
D 11 (0.2%)
Disability 8 (0.1%)
Congenital Anomaly 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Material Separation 543
Mechanical Problem 377
Material Deformation 358
Fluid/Blood Leak 276
Crack 252
Adverse Event Without Identified Device or Use Problem 243
Delivered as Unsterile Product 220
Material Puncture/Hole 193
Contamination 177
Obstruction of Flow 142
Break 112
Detachment of Device or Device Component 77
Misassembled During Installation 73
Leak/Splash 69
Device Markings/Labelling Problem 57
Disconnection 56
Air/Gas in Device 54
Packaging Problem 54
Fracture 50
Insufficient Information 45

Yearly Trend

92
1992: 5
93
1993: 4
94
1994: 3
95
1995: 2
96
1996: 19
97
1997: 81
98
1998: 91
99
1999: 72
00
2000: 37
01
2001: 62
02
2002: 27
03
2003: 59
04
2004: 70
05
2005: 80
06
2006: 96
07
2007: 121
08
2008: 126
09
2009: 99
10
2010: 197
11
2011: 212
12
2012: 233
13
2013: 238
14
2014: 325
15
2015: 218
16
2016: 144
17
2017: 101
18
2018: 118
19
2019: 179
20
2020: 142
21
2021: 162
22
2022: 276
23
2023: 470
24
2024: 401
25
2025: 1,030
26
2026: 258

Related Entities for Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Top Manufacturers

PERFUSION SYSTEMS 1,416
EDWARDS LIFESCIENCES 998
MEDTRONIC MEXICO S. DE R.L. DE CV 377
MEDTRONIC MEXICO 279
MAQUET CARDIOPULMONARY GMBH 217
MAQUET CARDIOPULMONARY AG 191
TERUMO CARDIOVASCULAR SYSTEMS CORP. 159
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 98

Event Locations

3,326 (57.8%)
HOSPITAL 1,500 (26.1%)
I 841 (14.6%)
NO INFORMATION 36 (0.6%)
INVALID DATA 30 (0.5%)
OTHER 13 (0.2%)
HOME 6 (0.1%)
UNKNOWN 3 (0.1%)
HOSPICE 1 (0.0%)
OPERATING ROOM 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare PERFUSION SYSTEMS vs EDWARDS LIFESCIENCES →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for 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 (5,758 here).

Holder, Head, Neurosurgical 5,752 Instrument 5,802 Drug-Eluting Peripheral Transluminal Angiop… 5,692 Mesh 5,826

Similar death-typed counts

Nearest other device types by death-typed report count (288 here), distinct from the volume row.

Port & Catheter 293 Catheter, Hemodialysis, Implanted 297 Catheter 300 Acid, Hyaluronic, Intraarticular 301

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.