Catheter, Peripheral, Atherectomy
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 §870.4875 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Catheter, Peripheral, Atherectomy LIGHT-BOOK · MAUDE
#237 of 1000 · 8,451 reports · 1994–2026
- BOOK 8,451 reports
- RANK #237 of 1000
- DEATH 149 death-typed
- INJ 3,462 injury-typed
- MALF 4,687 malfunction
- SPAN 1994–2026
- PEAK 2021: 734
- PHOTO Dialyzer
Nearest event-volume peer: Dialyzer, Capillary, Hollow Fiber (27 report gap)
Catheter, Peripheral, Atherectomy sits #237 of 1000 among tracked device types with 8,451 MAUDE reports spanning 1994–2026. 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 →
Injury-coded reports run above the device-type norm
Catheter, Peripheral, Atherectomy carries 41.0% INJURY-coded reports, 10.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.8% corpus 1.5% · near corpus mean (+0.3 pp)
- INJ 41.0% corpus 30.3% · above corpus mean (+10.7 pp)
- MALF 55.5% corpus 64.8% · below corpus mean (-9.4 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 15% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 35% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .
Catheter, Peripheral, Atherectomy in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Guide
Guide, Surgical, Instrument
8,485 reports
- Catheter (this)
Catheter, Peripheral, Atherectomy
8,451 reports
- Dialyzer
Dialyzer, Capillary, Hollow Fiber
8,424 reports
- Acid
Acid, Hyaluronic, Intraarticular
8,410 reports
- Abutment
Abutment, Implant, Dental, Endosseous
8,409 reports
- Hysteroscope
Hysteroscope (And Accessories)
8,394 reports
What this shows Catheter, Peripheral, Atherectomy carries 8,451 MAUDE reports, ranked #237 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 (689) held close to the prior two-year average of 626.
Related Entities for Catheter, Peripheral, Atherectomy
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs MEDTRONIC IRELAND →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Peripheral, Atherectomy: 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 (8,451 here).
Similar death-typed counts
Nearest other device types by death-typed report count (149 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter, Peripheral, Atherectomy 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, Peripheral, Atherectomy; 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.