Introducer, Catheter
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 §870.1340 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Introducer, Catheter MID-BOOK · MAUDE
#85 of 1000 · 40,656 reports · 1992–2026
- BOOK 40,656 reports
- RANK #85 of 1000
- DEATH 1,345 death-typed
- INJ 12,708 injury-typed
- MALF 26,267 malfunction
- SPAN 1992–2026
- PEAK 2025: 4,594
- PHOTO Unit
Nearest event-volume peer: Unit, Phacofragmentation (562 report gap)
Introducer, Catheter sits #85 of 1000 among tracked device types with 40,656 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 →
Death-coded reports run above the device-type norm
Introducer, Catheter carries 3.3% DEATH-coded reports, 1.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 3.3% corpus 1.5% · above corpus mean (+1.8 pp)
- INJ 31.3% corpus 30.3% · above corpus mean (+1.0 pp)
- MALF 64.6% corpus 64.8% · near corpus mean (-0.2 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 15% of coded problems · Lead manufacturer BIOSENSE WEBSTER INC accounts for 23% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .
Introducer, Catheter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Clip
Clip, Implantable
42,204 reports
- Catheter
Catheter, Percutaneous
41,518 reports
- Unit
Unit, Phacofragmentation
41,218 reports
- Introducer (this)
Introducer, Catheter
40,656 reports
- Needle
Needle, Hypodermic, Single Lumen
39,692 reports
- Plate
Plate, Fixation, Bone
38,818 reports
What this shows Introducer, Catheter carries 40,656 MAUDE reports, ranked #85 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 (4,594) held close to the prior two-year average of 3,853.
Related Entities for Introducer, Catheter
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Introducer, Catheter: 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 (40,656 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1,345 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Introducer, Catheter 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 Introducer, Catheter; 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.