Heart-Valve, Mechanical
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, Mechanical LIGHT-BOOK · MAUDE
#264 of 1000 · 7,067 reports · 1992–2026
- BOOK 7,067 reports
- RANK #264 of 1000
- DEATH 901 death-typed
- INJ 5,360 injury-typed
- MALF 718 malfunction
- SPAN 1992–2026
- PEAK 2000: 513
- PHOTO Hearing Aid
Nearest event-volume peer: Hearing Aid, Bone Conduction (49 report gap)
Heart-Valve, Mechanical sits #264 of 1000 among tracked device types with 7,067 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 sit below the device-type norm
Heart-Valve, Mechanical carries 10.2% MALFUNCTION-coded reports, 54.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 12.7% corpus 1.5% · above corpus mean (+11.2 pp)
- INJ 75.8% corpus 30.3% · above corpus mean (+45.6 pp)
- MALF 10.2% corpus 64.8% · below corpus mean (-54.7 pp)
Lead product-problem code Explanted is 21% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC. accounts for 33% of manufacturer-tagged reports · Top event location is 38% of location-tagged rows .
Heart-Valve, Mechanical in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Stent, Iliac
Stent, Iliac
7,218 reports
- Hemostatic Me…
Hemostatic Metal Clip For The Gi Tract
7,146 reports
- Hearing Aid
Hearing Aid, Bone Conduction
7,116 reports
- Heart-Valve (this)
Heart-Valve, Mechanical
7,067 reports
- Warmer
Warmer, Thermal, Infusion Fluid
6,999 reports
- Prosthesis
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
6,959 reports
What this shows Heart-Valve, Mechanical carries 7,067 MAUDE reports, ranked #264 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 (336) held close to the prior two-year average of 430.
Related Entities for Heart-Valve, Mechanical
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Heart-Valve, Mechanical: 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 (7,067 here).
Similar death-typed counts
Nearest other device types by death-typed report count (901 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Heart-Valve, Mechanical 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, Mechanical; 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.