Set, Administration, Intravascular
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 §880.5440 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Set, Administration, Intravascular HEAVY-BOOK · MAUDE
#14 of 1000 · 309,977 reports · 1992–2026
- BOOK 309,977 reports
- RANK #14 of 1000
- DEATH 779 death-typed
- INJ 58,059 injury-typed
- MALF 249,611 malfunction
- SPAN 1992–2026
- PEAK 2026: 106,588
- PHOTO Ventilator
Nearest event-volume peer: Ventilator, Non-Continuous (Respirator) (9,079 report gap)
Set, Administration, Intravascular sits #14 of 1000 among tracked device types with 309,977 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 →
Malfunction reports run above the device-type norm
Set, Administration, Intravascular carries 80.5% MALFUNCTION-coded reports, 15.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.3% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 18.7% corpus 30.3% · below corpus mean (-11.6 pp)
- MALF 80.5% corpus 64.8% · above corpus mean (+15.7 pp)
Lead product-problem code Fluid/Blood Leak is 15% of coded problems · Lead manufacturer UNOMEDICAL A/S accounts for 38% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .
Set, Administration, Intravascular in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Permanent Pac…
Permanent Pacemaker Electrode
325,343 reports
- Sensor
Sensor, Glucose, Invasive, Non-Adjunctive
324,715 reports
- Set (this)
Set, Administration, Intravascular
309,977 reports
- Ventilator
Ventilator, Non-Continuous (Respirator)
300,898 reports
- Sensor
Sensor, Glucose, Invasive
281,941 reports
- Automated Ext…
Automated External Defibrillators (Non-Wearable)
268,697 reports
What this shows Set, Administration, Intravascular carries 309,977 MAUDE reports, ranked #14 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 in 2025 (35,052) held close to the prior two-year average of 29,063.
Related Entities for Set, Administration, Intravascular
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Set, Administration, Intravascular: 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 (309,977 here).
Similar death-typed counts
Nearest other device types by death-typed report count (779 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Set, Administration, Intravascular 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 Set, Administration, Intravascular; 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.