PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Angiography/Angioplasty 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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.1650 (Cardiovascular panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Angiography/Angioplasty Kit LIGHT-BOOK · MAUDE

#896 of 1000 · 494 reports · 2011–2026

  • BOOK 494 reports
  • RANK #896 of 1000
  • DEATH 1 death-typed
  • INJ 25 injury-typed
  • MALF 467 malfunction
  • SPAN 2011–2026
  • PEAK 2025: 111
  • PHOTO Joint

Nearest event-volume peer: Joint, Knee, External Limb Component (0 report gap)

Angiography/Angioplasty Kit sits #896 of 1000 among tracked device types with 494 MAUDE reports spanning 2011–2026. 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

Angiography/Angioplasty Kit carries 94.5% MALFUNCTION-coded reports, 29.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 5.1% corpus 30.3% · below corpus mean (-25.2 pp)
  • MALF 94.5% corpus 64.8% · above corpus mean (+29.7 pp)

Lead product-problem code Unsealed Device Packaging is 27% of coded problems · Lead manufacturer MERIT MEDICAL SYSTEMS INC. accounts for 80% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Angiography/Angioplasty Kit in the event-volume neighbourhood

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

reports

What this shows Angiography/Angioplasty Kit carries 494 MAUDE reports, ranked #896 of 1000.

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

Event Types

Malfunction 467 (94.5%)
Injury 25 (5.1%)
Death 1 (0.2%)
Other 1 (0.2%)

Patient Outcomes

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

418 (83.3%)
Other 57 (11.4%)
Required Intervention 12 (2.4%)
Hospitalization 5 (1.0%)
R 4 (0.8%)
L 3 (0.6%)
O 1 (0.2%)
Death 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Unsealed Device Packaging 149
Tear, Rip or Hole in Device Packaging 132
Material Separation 33
Packaging Problem 28
Manufacturing, Packaging or Shipping Problem 27
No Apparent Adverse Event 27
Material Frayed 16
Fracture 15
Material Integrity Problem 15
Break 13
Device Contaminated During Manufacture or Shipping 13
Connection Problem 12
Contamination /Decontamination Problem 11
Fluid/Blood Leak 9
Adverse Event Without Identified Device or Use Problem 8
Contamination 8
Device Contamination with Chemical or Other Material 8
Appropriate Device Problem Term/Code Not Available 7
Material Fragmentation 7
Crack 5

Yearly Trend

11
2011: 1
13
2013: 1
15
2015: 1
16
2016: 3
17
2017: 3
18
2018: 14
19
2019: 22
20
2020: 64
21
2021: 54
22
2022: 81
23
2023: 56
24
2024: 62
25
2025: 111
26
2026: 21

Reports rose to 111 in 2025, up from an average of 59 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Angiography/Angioplasty Kit

Top Manufacturers

MERIT MEDICAL SYSTEMS INC. 249
MERIT MEDICAL SYSTEMS, INC. 43
MEDLINE INDUSTRIES, LP 19

Event Locations

326 (66.0%)
I 141 (28.5%)
HOSPITAL 23 (4.7%)
NO INFORMATION 3 (0.6%)
OTHER 1 (0.2%)

Compare MERIT MEDICAL SYSTEMS INC. vs MERIT MEDICAL SYSTEMS, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Angiography/Angioplasty Kit: 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 (494 here).

Joint, Knee, External Limb Component 494 Glue, Surgical, Arteries 495 Blood Pressure Cuff 492 Enzyme Linked Immunoabsorption Assay 492

Similar death-typed counts

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

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Angiography/Angioplasty 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 Angiography/Angioplasty 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.