Catheter, Percutaneous
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 §870.1250 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Catheter, Percutaneous MID-BOOK · MAUDE
#83 of 1000 · 41,518 reports · 1992–2026
- BOOK 41,518 reports
- RANK #83 of 1000
- DEATH 903 death-typed
- INJ 9,413 injury-typed
- MALF 31,029 malfunction
- SPAN 1992–2026
- PEAK 2024: 3,189
- PHOTO Unit
Nearest event-volume peer: Unit, Phacofragmentation (300 report gap)
Catheter, Percutaneous sits #83 of 1000 among tracked device types with 41,518 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
Catheter, Percutaneous carries 74.7% MALFUNCTION-coded reports, 9.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
- INJ 22.7% corpus 30.3% · below corpus mean (-7.6 pp)
- MALF 74.7% corpus 64.8% · above corpus mean (+9.9 pp)
Lead product-problem code Material Rupture is 19% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 21% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .
Catheter, Percutaneous in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Neurological…
Neurological Stereotaxic Instrument
42,726 reports
- Clip
Clip, Implantable
42,204 reports
- Catheter (this)
Catheter, Percutaneous
41,518 reports
- Unit
Unit, Phacofragmentation
41,218 reports
- Introducer
Introducer, Catheter
40,656 reports
- Needle
Needle, Hypodermic, Single Lumen
39,692 reports
What this shows Catheter, Percutaneous carries 41,518 MAUDE reports, ranked #83 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 (3,096) held close to the prior two-year average of 3,119.
Related Entities for Catheter, Percutaneous
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs BARD PERIPHERAL VASCULAR, INC. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Percutaneous: 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 (41,518 here).
Similar death-typed counts
Nearest other device types by death-typed report count (903 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter, Percutaneous 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 Catheter, Percutaneous; 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.