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2026 data FDA MAUDE openFDA

Occluder, Patent Ductus, Arteriosus

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.

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FDA MAUDE casebook

openFDA event book Occluder, Patent Ductus, Arteriosus LIGHT-BOOK · MAUDE

#658 of 1000 · 994 reports · 2001–2026

  • BOOK 994 reports
  • RANK #658 of 1000
  • DEATH 54 death-typed
  • INJ 621 injury-typed
  • MALF 317 malfunction
  • SPAN 2001–2026
  • PEAK 2025: 180
  • PHOTO Electrode

Nearest event-volume peer: Electrode, Ion Specific, Potassium (0 report gap)

Occluder, Patent Ductus, Arteriosus sits #658 of 1000 among tracked device types with 994 MAUDE reports spanning 2001–2026. 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 5.4% corpus 1.5% · above corpus mean (+3.9 pp)
  • INJ 62.5% corpus 30.4% · above corpus mean (+32.0 pp)
  • MALF 31.9% corpus 64.5% · below corpus mean (-32.6 pp)

Lead product-problem code Migration or Expulsion of Device is 28% of coded problems · Lead manufacturer ABBOTT MEDICAL accounts for 99% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Occluder, Patent Ductus, Arteriosus in the event-volume neighbourhood

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

reports

What this shows Occluder, Patent Ductus, Arteriosus carries 994 MAUDE reports, ranked #658 of 1000.

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

Event Types

Injury 621 (62.5%)
Malfunction 317 (31.9%)
Death 54 (5.4%)
2 (0.2%)

Patient Outcomes

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

Required Intervention 460 (37.4%)
275 (22.4%)
R 149 (12.1%)
Hospitalization 113 (9.2%)
Other 63 (5.1%)
Death 53 (4.3%)
H 36 (2.9%)
L 24 (2.0%)
Life Threatening 22 (1.8%)
O 20 (1.6%)
S 6 (0.5%)
Disability 4 (0.3%)
D 2 (0.2%)
Congenital Anomaly 2 (0.2%)

Top Product Problems

Migration or Expulsion of Device 280
Difficult to Fold, Unfold or Collapse 180
Adverse Event Without Identified Device or Use Problem 114
Patient Device Interaction Problem 77
Off-Label Use 59
Improper or Incorrect Procedure or Method 55
Material Deformation 50
Unintended Movement 35
Migration 21
Obstruction of Flow 19
Malposition of Device 17
Patient-Device Incompatibility 15
Inadequacy of Device Shape and/or Size 14
Use of Device Problem 13
Human-Device Interface Problem 11
Premature Separation 11
Biocompatibility 9
Insufficient Information 8
Difficult to Insert 6
Gradient Increase 6

Yearly Trend

01
2001: 1
03
2003: 1
04
2004: 1
07
2007: 2
08
2008: 12
09
2009: 15
10
2010: 18
11
2011: 18
12
2012: 19
13
2013: 16
14
2014: 28
15
2015: 24
16
2016: 12
17
2017: 23
18
2018: 28
19
2019: 53
20
2020: 109
21
2021: 76
22
2022: 80
23
2023: 127
24
2024: 117
25
2025: 180
26
2026: 34

Related Entities for Occluder, Patent Ductus, Arteriosus

Top Manufacturers

ABBOTT MEDICAL 598
ST. JUDE MEDICAL 5
ST. JUDE MEDICAL, INC. 4

Event Locations

693 (69.7%)
I 279 (28.1%)
HOSPITAL 13 (1.3%)
NO INFORMATION 8 (0.8%)
NOT APPLICABLE 1 (0.1%)

Compare ABBOTT MEDICAL vs ST. JUDE MEDICAL →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Occluder, Patent Ductus, Arteriosus, 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 (994 here).

Electrode, Ion Specific, Potassium 994 Mouthguard, Over-The-Counter 992 Stabilizer, Heart 999 Prosthesis 984

Similar death-typed counts

Nearest other device types by death-typed report count (54 here), distinct from the volume row.

Wheelchair, Mechanical 54 Bottle, Collection, Vacuum 55 Catheter, Balloon Type 55 Computer, Diagnostic, Programmable 53

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Occluder, Patent Ductus, Arteriosus 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 Occluder, Patent Ductus, Arteriosus; 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.