2026 data FDA MAUDE openFDA

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

#160 of 1000 · 16,214 reports · 2009–2026

  • BOOK 16,214 reports
  • RANK #160 of 1000
  • DEATH 1,702 death-typed
  • INJ 12,690 injury-typed
  • MALF 1,821 malfunction
  • SPAN 2009–2026
  • PEAK 2025: 2,859
  • PHOTO Applier

Nearest event-volume peer: Applier, Surgical, Clip (66 report gap)

System, Appendage Closure, Left Atrial sits #160 of 1000 among tracked device types with 16,214 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 →

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 10.5% corpus 1.5% · above corpus mean (+9.0 pp)
  • INJ 78.3% corpus 30.4% · above corpus mean (+47.8 pp)
  • MALF 11.2% corpus 64.5% · below corpus mean (-53.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 67% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 70% of manufacturer-tagged reports · Top event location is 65% 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 16,214 MAUDE reports, ranked #160 of 1000.

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

Event Types

Injury 12,690 (78.3%)
Malfunction 1,821 (11.2%)
Death 1,702 (10.5%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 5,368 (28.2%)
Other 4,601 (24.1%)
3,899 (20.4%)
R 1,143 (6.0%)
Death 1,074 (5.6%)
Hospitalization 1,058 (5.5%)
H 916 (4.8%)
O 399 (2.1%)
L 206 (1.1%)
D 138 (0.7%)
Life Threatening 131 (0.7%)
S 79 (0.4%)
Disability 57 (0.3%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 11,080
Difficult to Open or Close 734
Migration 653
Device Dislodged or Dislocated 624
Migration or Expulsion of Device 460
Difficult to Remove 458
Material Deformation 444
Patient Device Interaction Problem 367
Patient-Device Incompatibility 344
Material Integrity Problem 274
Failure to Seal 242
Detachment of Device or Device Component 169
Leak/Splash 135
Kinked 131
Improper or Incorrect Procedure or Method 111
Use of Device Problem 65
Insufficient Information 60
Gas/Air Leak 49
Difficult to Fold, Unfold or Collapse 46
Premature Separation 46

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: 679

Related Entities for System, Appendage Closure, Left Atrial

Event Locations

10,497 (64.7%)
I 5,668 (35.0%)
HOSPITAL 21 (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 similar MAUDE profiles

Two openFDA-derived peer sets for System, Appendage Closure, Left Atrial, 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 (16,214 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1,702 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.