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2026 data FDA MAUDE openFDA

Cardiovascular Procedure Kit

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 Cardiovascular Procedure Kit LIGHT-BOOK · MAUDE

#624 of 1000 · 1,129 reports · 2010–2026

  • BOOK 1,129 reports
  • RANK #624 of 1000
  • DEATH 17 death-typed
  • INJ 135 injury-typed
  • MALF 951 malfunction
  • SPAN 2010–2026
  • PEAK 2010: 199
  • PHOTO Bariatric Bed

Nearest event-volume peer: Bariatric Bed (4 report gap)

Cardiovascular Procedure Kit sits #624 of 1000 among tracked device types with 1,129 MAUDE reports spanning 2010–2026. 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 1.5% corpus 1.5% · near corpus mean (-0.0 pp)
  • INJ 12.0% corpus 30.4% · below corpus mean (-18.5 pp)
  • MALF 84.2% corpus 64.5% · above corpus mean (+19.7 pp)

Lead product-problem code Connection Problem is 20% of coded problems · Lead manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORPORATION accounts for 66% of manufacturer-tagged reports · Top event location HOSPITAL is 41% of location-tagged rows .

Cardiovascular Procedure Kit in the event-volume neighbourhood

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

reports

What this shows Cardiovascular Procedure Kit carries 1,129 MAUDE reports, ranked #624 of 1000.

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

Event Types

Malfunction 951 (84.2%)
Injury 135 (12.0%)
20 (1.8%)
Death 17 (1.5%)
Other 6 (0.5%)

Patient Outcomes

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

773 (66.5%)
Other 206 (17.7%)
Required Intervention 99 (8.5%)
Life Threatening 24 (2.1%)
R 21 (1.8%)
Death 17 (1.5%)
Hospitalization 5 (0.4%)
H 4 (0.3%)
L 4 (0.3%)
O 4 (0.3%)
S 3 (0.3%)
Disability 2 (0.2%)

Top Product Problems

Connection Problem 110
Fluid/Blood Leak 54
Tear, Rip or Hole in Device Packaging 42
Break 37
Leak/Splash 37
Disconnection 33
Appropriate Term/Code Not Available 26
Air Leak 25
Crack 24
Adverse Event Without Identified Device or Use Problem 23
Loose or Intermittent Connection 22
Material Fragmentation 19
Problem with Sterilization 19
Device Contamination with Chemical or Other Material 16
Material Integrity Problem 16
Material Frayed 13
Insufficient Information 12
Contamination /Decontamination Problem 11
Material Separation 11
Unsealed Device Packaging 11

Yearly Trend

10
2010: 199
11
2011: 185
12
2012: 28
13
2013: 7
14
2014: 10
15
2015: 28
16
2016: 44
17
2017: 42
18
2018: 58
19
2019: 71
20
2020: 65
21
2021: 42
22
2022: 36
23
2023: 24
24
2024: 147
25
2025: 123
26
2026: 20

Related Entities for Cardiovascular Procedure Kit

Top Manufacturers

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 416
ANGIODYNAMICS 69
MERIT MEDICAL SYSTEMS INC. 55
TERUMO CARDIOVASCULAR SYSTEMS CORP. 52
TERUMO CARDIOVASCULAR SYSTEMS CORP 35

Event Locations

HOSPITAL 463 (41.0%)
345 (30.6%)
I 298 (26.4%)
NO INFORMATION 21 (1.9%)
HOME 1 (0.1%)
OTHER 1 (0.1%)

Compare TERUMO CARDIOVASCULAR SYSTEMS CORPORATION vs ANGIODYNAMICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Cardiovascular Procedure Kit, 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 (1,129 here).

Bariatric Bed 1,133 Prosthesis 1,123 Surgical Film 1,137 System, Monitoring, Perinatal 1,142

Similar death-typed counts

Nearest other device types by death-typed report count (17 here), distinct from the volume row.

Accessories, Blood Circuit, Hemodialysis 17 Agent, Occluding, Vascular, Permanent 17 Cable, Transducer And Electrode, Patient, 17 Counter, Differential Cell 17

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

Disclaimer: MAUDE figures for Cardiovascular Procedure Kit 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 Cardiovascular Procedure Kit; 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.