Heart-Valve, Non-Allograft Tissue
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 MAUDE casebook
openFDA event book Heart-Valve, Non-Allograft Tissue MID-BOOK · MAUDE
#122 of 1000 · 25,471 reports · 1993–2026
- BOOK 25,471 reports
- RANK #122 of 1000
- DEATH 2,037 death-typed
- INJ 21,946 injury-typed
- MALF 1,232 malfunction
- SPAN 1993–2026
- PEAK 2025: 1,884
- PHOTO Arthroscope
Nearest event-volume peer: Arthroscope (20 report gap)
Heart-Valve, Non-Allograft Tissue sits #122 of 1000 among tracked device types with 25,471 MAUDE reports spanning 1993–2026. 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 sit below the device-type norm
Heart-Valve, Non-Allograft Tissue carries 4.8% MALFUNCTION-coded reports, 60.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 8.0% corpus 1.5% · above corpus mean (+6.5 pp)
- INJ 86.2% corpus 30.3% · above corpus mean (+55.9 pp)
- MALF 4.8% corpus 64.8% · below corpus mean (-60.0 pp)
Lead product-problem code Insufficient Device Problem Information is 22% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 51% of manufacturer-tagged reports · Top event location is 39% of location-tagged rows .
Heart-Valve, Non-Allograft Tissue in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
25,951 reports
- Fastener
Fastener, Fixation, Nondegradable, Soft Tissue
25,623 reports
- Arthroscope
Arthroscope
25,491 reports
- Heart-Valve (this)
Heart-Valve, Non-Allograft Tissue
25,471 reports
- Shunt
Shunt, Central Nervous System And Components
25,418 reports
- Mitral Valve…
Mitral Valve Repair Devices
25,400 reports
What this shows Heart-Valve, Non-Allograft Tissue carries 25,471 MAUDE reports, ranked #122 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 (1,884) held close to the prior two-year average of 1,711.
Related Entities for Heart-Valve, Non-Allograft Tissue
Top Manufacturers
Event Locations
Compare EDWARDS LIFESCIENCES vs MEDTRONIC HEART VALVES DIVISION →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Heart-Valve, Non-Allograft Tissue: 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 (25,471 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2,037 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Heart-Valve, Non-Allograft Tissue 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 Heart-Valve, Non-Allograft Tissue; 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.