Catheters, Transluminal Coronary Angioplasty, 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 §870.5100 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Catheters MID-BOOK · MAUDE
#80 of 1000 · 43,512 reports · 1992–2026
- BOOK 43,512 reports
- RANK #80 of 1000
- DEATH 583 death-typed
- INJ 5,627 injury-typed
- MALF 37,205 malfunction
- SPAN 1992–2026
- PEAK 2017: 2,753
- PHOTO Dialyzer
Nearest event-volume peer: Dialyzer, High Permeability With Or Without Sealed Dialysate System (40 report gap)
Catheters, Transluminal Coronary Angioplasty, Percutaneous sits #80 of 1000 among tracked device types with 43,512 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
Catheters carries 85.5% MALFUNCTION-coded reports, 20.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
- INJ 12.9% corpus 30.3% · below corpus mean (-17.4 pp)
- MALF 85.5% corpus 64.8% · above corpus mean (+20.7 pp)
Lead product-problem code Material Rupture is 31% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 23% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .
Catheters in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Temporary Non…
Temporary Non-Roller Type Left Heart Support Blood Pump
44,306 reports
- Powered Laser…
Powered Laser Surgical Instrument
44,086 reports
- Stimulator
Stimulator, Spinal-Cord, Implanted (Pain Relief)
43,932 reports
- Dialyzer
Dialyzer, High Permeability With Or Without Sealed Dialysate System
43,552 reports
- Catheters (this)
Catheters, Transluminal Coronary Angioplasty, Percutaneous
43,512 reports
- Neurological…
Neurological Stereotaxic Instrument
42,726 reports
What this shows Catheters, Transluminal Coronary Angioplasty, Percutaneous carries 43,512 MAUDE reports, ranked #80 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 (1,922) held close to the prior two-year average of 1,762.
Related Entities for Catheters, Transluminal Coronary Angioplasty, Percutaneous
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheters: 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 (43,512 here).
Similar death-typed counts
Nearest other device types by death-typed report count (583 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheters 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 Catheters; 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.