Dilator, Vessel, For Percutaneous Catheterization
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 §870.1310 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Dilator LIGHT-BOOK · MAUDE
#393 of 1000 · 3,156 reports · 1993–2026
- BOOK 3,156 reports
- RANK #393 of 1000
- DEATH 185 death-typed
- INJ 1,658 injury-typed
- MALF 1,296 malfunction
- SPAN 1993–2026
- PEAK 2023: 386
- PHOTO Endoscopic Tissue App…
Nearest event-volume peer: Endoscopic Tissue Approximation Device (2 report gap)
Dilator, Vessel, For Percutaneous Catheterization sits #393 of 1000 among tracked device types with 3,156 MAUDE reports spanning 1993–2026. 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 sit below the device-type norm
Dilator carries 41.1% MALFUNCTION-coded reports, 23.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 5.9% corpus 1.5% · above corpus mean (+4.4 pp)
- INJ 52.5% corpus 30.3% · above corpus mean (+22.2 pp)
- MALF 41.1% corpus 64.8% · below corpus mean (-23.8 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 28% of coded problems · Lead manufacturer CORDIS DE MEXICO accounts for 29% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .
Dilator in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Measurement, Blood-Pressure, Non-Invasive
3,169 reports
- Apparatus
Apparatus, Autotransfusion
3,163 reports
- Dilator (this)
Dilator, Vessel, For Percutaneous Catheterization
3,156 reports
- Endoscopic Ti…
Endoscopic Tissue Approximation Device
3,154 reports
- Saline
Saline, Vascular Access Flush
3,148 reports
- Dressing
Dressing, Wound, Drug
3,144 reports
What this shows Dilator, Vessel, For Percutaneous Catheterization carries 3,156 MAUDE reports, ranked #393 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 (357) held close to the prior two-year average of 356.
Related Entities for Dilator, Vessel, For Percutaneous Catheterization
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Dilator: 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 (3,156 here).
Similar death-typed counts
Nearest other device types by death-typed report count (185 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Dilator 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 Dilator; 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.