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
#121 of 1000 · 24,466 reports · 1993–2026
- BOOK 24,466 reports
- RANK #121 of 1000
- DEATH 1,996 death-typed
- INJ 21,062 injury-typed
- MALF 1,152 malfunction
- SPAN 1993–2026
- PEAK 2025: 1,884
- PHOTO Arthroscope
Nearest event-volume peer: Arthroscope (191 report gap)
Heart-Valve, Non-Allograft Tissue sits #121 of 1000 among tracked device types with 24,466 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 →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 8.2% corpus 1.5% · above corpus mean (+6.6 pp)
- INJ 86.1% corpus 30.4% · above corpus mean (+55.6 pp)
- MALF 4.7% corpus 64.5% · below corpus mean (-59.8 pp)
Lead product-problem code Insufficient Information is 30% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 51% of manufacturer-tagged reports · Top event location is 36% 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
- Tubes
Tubes, Gastrointestinal (And Accessories)
25,062 reports
- Shunt
Shunt, Central Nervous System And Components
24,906 reports
- Arthroscope
Arthroscope
24,657 reports
- Heart-Valve (this)
Heart-Valve, Non-Allograft Tissue
24,466 reports
- Thoracolumbos…
Thoracolumbosacral Pedicle Screw System
24,083 reports
- Programmer
Programmer, Pacemaker
23,727 reports
What this shows Heart-Valve, Non-Allograft Tissue carries 24,466 MAUDE reports, ranked #121 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
Related Entities for Heart-Valve, Non-Allograft Tissue
Top Manufacturers
Event Locations
Compare EDWARDS LIFESCIENCES vs MEDTRONIC HEART VALVES DIVISION →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Heart-Valve, Non-Allograft Tissue, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (24,466 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1,996 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.