Catheter, Angioplasty, Peripheral, Transluminal
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 MID-BOOK · MAUDE
#96 of 1000 · 35,724 reports · 1992–2026
- BOOK 35,724 reports
- RANK #96 of 1000
- DEATH 181 death-typed
- INJ 5,396 injury-typed
- MALF 29,828 malfunction
- SPAN 1992–2026
- PEAK 2021: 2,492
- PHOTO Stretcher, Wheeled
Nearest event-volume peer: Stretcher, Wheeled (500 report gap)
Catheter, Angioplasty, Peripheral, Transluminal sits #96 of 1000 among tracked device types with 35,724 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 carries 83.5% MALFUNCTION-coded reports, 18.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
- INJ 15.1% corpus 30.3% · below corpus mean (-15.2 pp)
- MALF 83.5% corpus 64.8% · above corpus mean (+18.7 pp)
Lead product-problem code Material Rupture is 38% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 36% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .
Catheter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Hexokinase
Hexokinase, Glucose
37,534 reports
- Rod
Rod, Fixation, Intramedullary And Accessories
37,471 reports
- Replacement H…
Replacement Heart-Valve
37,100 reports
- Catheter
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
36,803 reports
- Catheter (this)
Catheter, Angioplasty, Peripheral, Transluminal
35,724 reports
- Stretcher
Stretcher, Wheeled
35,224 reports
What this shows Catheter, Angioplasty, Peripheral, Transluminal carries 35,724 MAUDE reports, ranked #96 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 (2,093) held close to the prior two-year average of 1,860.
Related Entities for Catheter, Angioplasty, Peripheral, Transluminal
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - MAPLE GROVE →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for 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 (35,724 here).
Similar death-typed counts
Nearest other device types by death-typed report count (181 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for 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 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.