2026 data FDA MAUDE openFDA FDA Class III

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.

FDA MAUDE casebook

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

#649 of 1000 · 1,071 reports · 2001–2026

  • BOOK 1,071 reports
  • RANK #649 of 1000
  • DEATH 60 death-typed
  • INJ 652 injury-typed
  • MALF 357 malfunction
  • SPAN 2001–2026
  • PEAK 2025: 180
  • PHOTO System

Nearest event-volume peer: System, Dialysate Delivery, Single Patient (1 report gap)

Occluder, Patent Ductus, Arteriosus sits #649 of 1000 among tracked device types with 1,071 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 →

Malfunction reports sit below the device-type norm

Occluder, Patent Ductus, Arteriosus carries 33.3% MALFUNCTION-coded reports, 31.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.6% corpus 1.5% · above corpus mean (+4.1 pp)
  • INJ 60.9% corpus 30.3% · above corpus mean (+30.6 pp)
  • MALF 33.3% corpus 64.8% · below corpus mean (-31.5 pp)

Lead product-problem code Migration or Expulsion of Device is 30% of coded problems · Lead manufacturer ABBOTT MEDICAL accounts for 98% of manufacturer-tagged reports · Top event location is 72% 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 1,071 MAUDE reports, ranked #649 of 1000.

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

Event Types

Injury 652 (60.9%)
Malfunction 357 (33.3%)
Death 60 (5.6%)
2 (0.2%)

Patient Outcomes

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

Required Intervention 481 (36.4%)
316 (23.9%)
R 157 (11.9%)
Hospitalization 121 (9.2%)
Other 65 (4.9%)
Death 56 (4.2%)
H 36 (2.7%)
L 25 (1.9%)
Life Threatening 23 (1.7%)
O 22 (1.7%)
S 8 (0.6%)
Disability 5 (0.4%)
D 4 (0.3%)
Congenital Anomaly 2 (0.2%)

Top Product Problems

Migration or Expulsion of Device 371
Difficult to Fold, Unfold or Collapse 205
Adverse Event Without Identified Device or Use Problem 138
Patient Device Interaction Problem 93
Off-Label Use 72
Improper or Incorrect Procedure or Method 57
Material Deformation 52
Unintended Movement 43
Malposition of Device 28
Inadequacy of Device Shape and/or Size 27
Device Dislodged or Dislocated 22
Migration 20
Obstruction of Flow 20
Patient-Device Incompatibility 18
Insufficient Device Problem Information 14
Use of Device Problem 14
Difficult to Remove 13
Premature Separation 12
Human-Device Interface Problem 11
Retraction Problem 11

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: 111

Reports rose to 180 in 2025, up from an average of 122 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Occluder, Patent Ductus, Arteriosus

Event Locations

770 (71.9%)
I 279 (26.1%)
HOSPITAL 13 (1.2%)
NO INFORMATION 8 (0.7%)
NOT APPLICABLE 1 (0.1%)

Compare ABBOTT MEDICAL vs ST. JUDE MEDICAL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Occluder, Patent Ductus, Arteriosus: 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 (1,071 here).

Similar death-typed counts

Nearest other device types by death-typed report count (60 here), distinct from the volume row.

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.