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2026 data FDA MAUDE openFDA

Transcatheter Septal Occluder

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Transcatheter Septal Occluder LIGHT-BOOK · MAUDE

#273 of 1000 · 6,503 reports · 1999–2026

  • BOOK 6,503 reports
  • RANK #273 of 1000
  • DEATH 182 death-typed
  • INJ 3,859 injury-typed
  • MALF 2,376 malfunction
  • SPAN 1999–2026
  • PEAK 2024: 843
  • PHOTO Tube, Tracheostomy

Nearest event-volume peer: Tube, Tracheostomy (W/Wo Connector) (19 report gap)

Transcatheter Septal Occluder sits #273 of 1000 among tracked device types with 6,503 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 →

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 2.8% corpus 1.5% · above corpus mean (+1.3 pp)
  • INJ 59.3% corpus 30.4% · above corpus mean (+28.9 pp)
  • MALF 36.5% corpus 64.5% · below corpus mean (-28.0 pp)

Lead product-problem code Difficult to Fold, Unfold or Collapse is 33% of coded problems · Lead manufacturer ABBOTT MEDICAL accounts for 74% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Transcatheter Septal Occluder in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Transcatheter Septal Occluder carries 6,503 MAUDE reports, ranked #273 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 3,859 (59.3%)
Malfunction 2,376 (36.5%)
Death 182 (2.8%)
56 (0.9%)
Other 30 (0.5%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 2,387 (30.2%)
2,236 (28.2%)
R 968 (12.2%)
Hospitalization 938 (11.8%)
Other 601 (7.6%)
Death 179 (2.3%)
H 177 (2.2%)
L 104 (1.3%)
O 94 (1.2%)
Life Threatening 93 (1.2%)
S 72 (0.9%)
Disability 33 (0.4%)
Congenital Anomaly 23 (0.3%)
D 12 (0.2%)

Top Product Problems

Difficult to Fold, Unfold or Collapse 1,623
Material Deformation 803
Adverse Event Without Identified Device or Use Problem 753
Migration or Expulsion of Device 417
Patient Device Interaction Problem 299
Patient-Device Incompatibility 161
Off-Label Use 145
Unintended Movement 140
Migration 119
Biocompatibility 97
Improper or Incorrect Procedure or Method 87
Insufficient Information 60
Device Dislodged or Dislocated 52
Human-Device Interface Problem 42
Inadequacy of Device Shape and/or Size 42
Difficult or Delayed Positioning 29
Material Protrusion/Extrusion 27
Break 25
Device Appears to Trigger Rejection 24
Fracture 21

Yearly Trend

99
1999: 3
00
2000: 8
01
2001: 12
02
2002: 44
03
2003: 50
04
2004: 68
05
2005: 82
06
2006: 100
07
2007: 103
08
2008: 178
09
2009: 187
10
2010: 186
11
2011: 201
12
2012: 189
13
2013: 134
14
2014: 103
15
2015: 133
16
2016: 123
17
2017: 140
18
2018: 212
19
2019: 406
20
2020: 407
21
2021: 487
22
2022: 504
23
2023: 672
24
2024: 843
25
2025: 776
26
2026: 152

Related Entities for Transcatheter Septal Occluder

Top Manufacturers

ABBOTT MEDICAL 2,820
W. L. GORE & ASSOCIATES, INC. 572
W.L. GORE & ASSOCIATES 389
ST. JUDE MEDICAL 14

Event Locations

4,631 (71.2%)
I 1,679 (25.8%)
HOSPITAL 160 (2.5%)
NO INFORMATION 18 (0.3%)
HOME 7 (0.1%)
INVALID DATA 2 (0.0%)
OTHER 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
UNKNOWN 2 (0.0%)

Compare ABBOTT MEDICAL vs W. L. GORE & ASSOCIATES, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Transcatheter Septal Occluder, 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 (6,503 here).

Tube, Tracheostomy 6,484 Separator, Automated, Blood Cell, Diagnostic 6,535 Hearing Aid, Bone Conduction, Implanted 6,463 Continuous, Ventilator, Home Use 6,546

Similar death-typed counts

Nearest other device types by death-typed report count (182 here), distinct from the volume row.

Duodenoscope And Accessories, Flexible/Rigid 182 Stent, Superficial Femoral Artery 181 Prosthesis 184 Catheter 179

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.