2026 data FDA MAUDE openFDA FDA Class III

System, Appendage Closure, Left Atrial

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 System, Appendage Closure, Left Atrial MID-BOOK · MAUDE

#158 of 1000 · 17,177 reports · 2009–2026

  • BOOK 17,177 reports
  • RANK #158 of 1000
  • DEATH 1,816 death-typed
  • INJ 13,486 injury-typed
  • MALF 1,874 malfunction
  • SPAN 2009–2026
  • PEAK 2025: 2,859
  • PHOTO Fastener

Nearest event-volume peer: Fastener, Fixation, Biodegradable, Soft Tissue (106 report gap)

System, Appendage Closure, Left Atrial sits #158 of 1000 among tracked device types with 17,177 MAUDE reports spanning 2009–2026. 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

System, Appendage Closure, Left Atrial carries 10.9% MALFUNCTION-coded reports, 53.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 10.6% corpus 1.5% · above corpus mean (+9.1 pp)
  • INJ 78.5% corpus 30.3% · above corpus mean (+48.2 pp)
  • MALF 10.9% corpus 64.8% · below corpus mean (-53.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 66% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 70% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

System, Appendage Closure, Left Atrial in the event-volume neighbourhood

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

reports

What this shows System, Appendage Closure, Left Atrial carries 17,177 MAUDE reports, ranked #158 of 1000.

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

Event Types

Injury 13,486 (78.5%)
Malfunction 1,874 (10.9%)
Death 1,816 (10.6%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 5,661 (27.8%)
Other 4,914 (24.2%)
3,954 (19.4%)
R 1,275 (6.3%)
Hospitalization 1,210 (6.0%)
Death 1,139 (5.6%)
H 1,049 (5.2%)
O 449 (2.2%)
L 218 (1.1%)
D 163 (0.8%)
Life Threatening 139 (0.7%)
S 96 (0.5%)
Disability 65 (0.3%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 11,841
Migration 738
Difficult to Open or Close 736
Device Dislodged or Dislocated 661
Migration or Expulsion of Device 508
Difficult to Remove 489
Material Deformation 470
Failure to Seal 414
Patient Device Interaction Problem 410
Patient-Device Incompatibility 399
Material Integrity Problem 273
Detachment of Device or Device Component 175
Leak/Splash 158
Kinked 143
Improper or Incorrect Procedure or Method 117
Use of Device Problem 69
Premature Separation 66
Insufficient Device Problem Information 61
Difficult to Fold, Unfold or Collapse 49
Gas/Air Leak 49

Yearly Trend

09
2009: 1
12
2012: 1
15
2015: 286
16
2016: 621
17
2017: 1,022
18
2018: 1,019
19
2019: 996
20
2020: 935
21
2021: 1,175
22
2022: 1,493
23
2023: 2,429
24
2024: 2,698
25
2025: 2,859
26
2026: 1,642

Reports in 2025 (2,859) held close to the prior two-year average of 2,564.

Related Entities for System, Appendage Closure, Left Atrial

Event Locations

11,459 (66.7%)
I 5,668 (33.0%)
HOSPITAL 22 (0.1%)
NO INFORMATION 21 (0.1%)
OTHER 4 (0.0%)
HOME 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs ABBOTT MEDICAL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Appendage Closure, Left Atrial: 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 (17,177 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1,816 here), distinct from the volume row.

Disclaimer: MAUDE figures for System, Appendage Closure, Left Atrial 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 System, Appendage Closure, Left Atrial; 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.