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.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.1200 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Cardiovascular Procedure Kit LIGHT-BOOK · MAUDE
#618 of 1000 · 1,221 reports · 2010–2026
- BOOK 1,221 reports
- RANK #618 of 1000
- DEATH 17 death-typed
- INJ 139 injury-typed
- MALF 1,039 malfunction
- SPAN 2010–2026
- PEAK 2010: 199
- PHOTO Accessories
Nearest event-volume peer: Accessories, Blood Circuit, Hemodialysis (1 report gap)
Cardiovascular Procedure Kit sits #618 of 1000 among tracked device types with 1,221 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 →
Malfunction reports run above the device-type norm
Cardiovascular Procedure Kit carries 85.1% MALFUNCTION-coded reports, 20.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
- INJ 11.4% corpus 30.3% · below corpus mean (-18.9 pp)
- MALF 85.1% corpus 64.8% · above corpus mean (+20.3 pp)
Lead product-problem code Leak/Splash is 19% of coded problems · Lead manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORPORATION accounts for 60% of manufacturer-tagged reports · Top event location HOSPITAL is 38% of location-tagged rows .
Cardiovascular Procedure Kit in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Tube
Tube, Gastro-Enterostomy
1,228 reports
- System/Device
System/Device, Pharmacy Compounding
1,226 reports
- Cardiovascula… (this)
Cardiovascular Procedure Kit
1,221 reports
- Accessories
Accessories, Blood Circuit, Hemodialysis
1,220 reports
- Hemodialyzer
Hemodialyzer, Re-Use, High Flux
1,219 reports
- System
System, X-Ray, Stationary
1,218 reports
What this shows Cardiovascular Procedure Kit carries 1,221 MAUDE reports, ranked #618 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 123 in 2025, up from an average of 86 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Cardiovascular Procedure Kit
Top Manufacturers
Event Locations
Compare TERUMO CARDIOVASCULAR SYSTEMS CORPORATION vs MEDLINE INDUSTRIES, LP →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Cardiovascular Procedure 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 (1,221 here).
Similar death-typed counts
Nearest other device types by death-typed report count (17 here), distinct from the volume row.
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.