Catheter, Septostomy
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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.5175 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Catheter, Septostomy LIGHT-BOOK · MAUDE
#482 of 1000 · 2,144 reports · 1994–2026
- BOOK 2,144 reports
- RANK #482 of 1000
- DEATH 104 death-typed
- INJ 1,371 injury-typed
- MALF 663 malfunction
- SPAN 1994–2026
- PEAK 2025: 692
- PHOTO Bottle
Nearest event-volume peer: Bottle, Collection, Vacuum (1 report gap)
Catheter, Septostomy sits #482 of 1000 among tracked device types with 2,144 MAUDE reports spanning 1994–2026. 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
Catheter, Septostomy carries 30.9% MALFUNCTION-coded reports, 33.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 4.9% corpus 1.5% · above corpus mean (+3.3 pp)
- INJ 63.9% corpus 30.3% · above corpus mean (+33.7 pp)
- MALF 30.9% corpus 64.8% · below corpus mean (-33.9 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 43% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 87% of manufacturer-tagged reports · Top event location is 89% of location-tagged rows .
Catheter, Septostomy in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Adaptor
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
2,152 reports
- Bottle
Bottle, Collection, Vacuum
2,145 reports
- Catheter (this)
Catheter, Septostomy
2,144 reports
- Device
Device, Irrigation, Ocular Surgery
2,143 reports
- Cutaneous Tis…
Cutaneous Tissue Adhesive With Mesh
2,139 reports
- Pancreatic St…
Pancreatic Stent, Covered, Metallic, Removable
2,138 reports
What this shows Catheter, Septostomy carries 2,144 MAUDE reports, ranked #482 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 rose to 692 in 2025, up from an average of 327 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Catheter, Septostomy
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Septostomy: 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 (2,144 here).
Similar death-typed counts
Nearest other device types by death-typed report count (104 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter, Septostomy 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 Catheter, Septostomy; 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.