Transcatheter Septal Occluder
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 Transcatheter Septal Occluder LIGHT-BOOK · MAUDE
#269 of 1000 · 6,884 reports · 1999–2026
- BOOK 6,884 reports
- RANK #269 of 1000
- DEATH 198 death-typed
- INJ 4,003 injury-typed
- MALF 2,597 malfunction
- SPAN 1999–2026
- PEAK 2024: 843
- PHOTO Prosthesis
Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing (2 report gap)
Transcatheter Septal Occluder sits #269 of 1000 among tracked device types with 6,884 MAUDE reports spanning 1999–2026. 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
Transcatheter Septal Occluder carries 58.1% INJURY-coded reports, 27.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.9% corpus 1.5% · above corpus mean (+1.4 pp)
- INJ 58.1% corpus 30.3% · above corpus mean (+27.9 pp)
- MALF 37.7% corpus 64.8% · below corpus mean (-27.1 pp)
Lead product-problem code Difficult to Fold, Unfold or Collapse is 26% of coded problems · Lead manufacturer ABBOTT MEDICAL accounts for 75% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .
Transcatheter Septal Occluder in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
6,959 reports
- Continuous
Continuous, Ventilator, Home Use
6,912 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
6,886 reports
- Transcatheter… (this)
Transcatheter Septal Occluder
6,884 reports
- Pad
Pad, Heating, Powered
6,878 reports
- Device
Device, Monitoring, Intracranial Pressure
6,841 reports
What this shows Transcatheter Septal Occluder carries 6,884 MAUDE reports, ranked #269 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 (776) held close to the prior two-year average of 758.
Related Entities for Transcatheter Septal Occluder
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Transcatheter Septal Occluder: 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 (6,884 here).
Similar death-typed counts
Nearest other device types by death-typed report count (198 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Transcatheter Septal Occluder 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 Transcatheter Septal Occluder; 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.