Cardiac Catheterization 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 §870.1200 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Cardiac Catheterization Kit LIGHT-BOOK · MAUDE
#907 of 1000 · 481 reports · 2012–2026
- BOOK 481 reports
- RANK #907 of 1000
- DEATH 2 death-typed
- INJ 50 injury-typed
- MALF 425 malfunction
- SPAN 2012–2026
- PEAK 2026: 122
- PHOTO Rongeur, Manual
Nearest event-volume peer: Rongeur, Manual (1 report gap)
Cardiac Catheterization Kit sits #907 of 1000 among tracked device types with 481 MAUDE reports spanning 2012–2026. 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
Cardiac Catheterization Kit carries 88.4% MALFUNCTION-coded reports, 23.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
- INJ 10.4% corpus 30.3% · below corpus mean (-19.9 pp)
- MALF 88.4% corpus 64.8% · above corpus mean (+23.5 pp)
Lead product-problem code Connection Problem is 15% of coded problems · Lead manufacturer MEDLINE INDUSTRIES, LP accounts for 64% of manufacturer-tagged reports · Top event location is 74% of location-tagged rows .
Cardiac Catheterization Kit in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Cane
Cane
484 reports
- Patient Exami…
Patient Examination Glove
484 reports
- Rongeur
Rongeur, Manual
482 reports
- Cardiac Cathe… (this)
Cardiac Catheterization Kit
481 reports
- Enzyme Immuno…
Enzyme Immunoassay, Digoxin
478 reports
- Scaffold
Scaffold, Dissection Repair
478 reports
What this shows Cardiac Catheterization Kit carries 481 MAUDE reports, ranked #907 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 117 in 2025, up from an average of 66 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Cardiac Catheterization Kit
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Cardiac Catheterization 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 (481 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Cardiac Catheterization 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 Cardiac Catheterization 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.