Valve, Pulmonary
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 Valve, Pulmonary LIGHT-BOOK · MAUDE
#501 of 1000 · 2,016 reports · 2018–2026
- BOOK 2,016 reports
- RANK #501 of 1000
- DEATH 179 death-typed
- INJ 1,713 injury-typed
- MALF 124 malfunction
- SPAN 2018–2026
- PEAK 2021: 405
- PHOTO Electrode
Nearest event-volume peer: Electrode, Pacemaker, Temporary (4 report gap)
Valve, Pulmonary sits #501 of 1000 among tracked device types with 2,016 MAUDE reports spanning 2018–2026. 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
Valve, Pulmonary carries 6.2% MALFUNCTION-coded reports, 58.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 8.9% corpus 1.5% · above corpus mean (+7.4 pp)
- INJ 85.0% corpus 30.3% · above corpus mean (+54.7 pp)
- MALF 6.2% corpus 64.8% · below corpus mean (-58.7 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 90% of coded problems · Lead manufacturer GYRUS ACMI, INC. accounts for 90% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .
Valve, Pulmonary in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Temporary Cor…
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
2,032 reports
- Tricuspid Val…
Tricuspid Valve Repair Device, Percutaneously Delivered
2,028 reports
- Apparatus
Apparatus, Suction, Ward Use, Portable, Ac-Powered
2,026 reports
- Pouch
Pouch, Colostomy
2,020 reports
- Valve (this)
Valve, Pulmonary
2,016 reports
- Electrode
Electrode, Pacemaker, Temporary
2,012 reports
What this shows Valve, Pulmonary carries 2,016 MAUDE reports, ranked #501 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 (148) held close to the prior two-year average of 221.
Related Entities for Valve, Pulmonary
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Valve, Pulmonary: 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 (2,016 here).
Similar death-typed counts
Nearest other device types by death-typed report count (179 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Valve, Pulmonary 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 Valve, Pulmonary; 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.