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2026 data FDA MAUDE openFDA FDA Class III

Artificial Heart

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 Artificial Heart LIGHT-BOOK · MAUDE

#366 of 1000 · 3,692 reports · 2000–2026

  • BOOK 3,692 reports
  • RANK #366 of 1000
  • DEATH 368 death-typed
  • INJ 301 injury-typed
  • MALF 3,011 malfunction
  • SPAN 2000–2026
  • PEAK 2018: 569
  • PHOTO Bone Cement

Nearest event-volume peer: Bone Cement, Antibiotic (5 report gap)

Artificial Heart sits #366 of 1000 among tracked device types with 3,692 MAUDE reports spanning 2000–2026. 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Artificial Heart carries 8.2% INJURY-coded reports, 22.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 10.0% corpus 1.5% · above corpus mean (+8.5 pp)
  • INJ 8.2% corpus 30.3% · below corpus mean (-22.1 pp)
  • MALF 81.6% corpus 64.8% · above corpus mean (+16.7 pp)

Lead product-problem code Device Displays Incorrect Message is 18% of coded problems · Top event location I is 59% of location-tagged rows .

Artificial Heart in the event-volume neighbourhood

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

reports

What this shows Artificial Heart carries 3,692 MAUDE reports, ranked #366 of 1000.

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

Event Types

Malfunction 3,011 (81.6%)
Death 368 (10.0%)
Injury 301 (8.2%)
Other 11 (0.3%)
1 (0.0%)

Patient Outcomes

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

2,999 (80.1%)
Death 359 (9.6%)
Other 183 (4.9%)
Required Intervention 83 (2.2%)
R 33 (0.9%)
Hospitalization 32 (0.9%)
Life Threatening 17 (0.5%)
O 11 (0.3%)
L 9 (0.2%)
H 7 (0.2%)
Disability 7 (0.2%)
D 4 (0.1%)
S 2 (0.1%)

Top Product Problems

Device Displays Incorrect Message 772
Audible Prompt/Feedback Problem 585
Adverse Event Without Identified Device or Use Problem 509
Device Operates Differently Than Expected 380
Battery Problem 323
Noise, Audible 245
Mechanical Problem 208
Appropriate Device Problem Term/Code Not Available 164
Electrical /Electronic Property Problem 139
Output Problem 119
Break 105
Power Problem 100
Charging Problem 97
Failure to Charge 91
No Apparent Adverse Event 89
Display or Visual Feedback Problem 77
Device Alarm System 71
Connection Problem 46
Material Integrity Problem 46
Device Inoperable 45

Yearly Trend

00
2000: 1
02
2002: 2
05
2005: 5
06
2006: 2
09
2009: 3
10
2010: 2
11
2011: 32
12
2012: 92
13
2013: 156
14
2014: 325
15
2015: 422
16
2016: 422
17
2017: 291
18
2018: 569
19
2019: 379
20
2020: 264
21
2021: 241
22
2022: 152
23
2023: 167
24
2024: 80
25
2025: 47
26
2026: 38

Reports fell to 47 in 2025, down from an average of 124 in the two years before.

Related Entities for Artificial Heart

Event Locations

I 2,170 (58.8%)
1,428 (38.7%)
NO INFORMATION 47 (1.3%)
HOSPITAL 26 (0.7%)
HOME 14 (0.4%)
OTHER 2 (0.1%)
UNKNOWN 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
INVALID DATA 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Artificial Heart: 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 (3,692 here).

Bone Cement, Antibiotic 3,697 Syringe, Balloon Inflation 3,683 Sensor 3,653 Tissue Adhesive For The Topical Approximati… 3,631

Similar death-typed counts

Nearest other device types by death-typed report count (368 here), distinct from the volume row.

Port & Catheter 373 Prosthesis 375 Mesh 376 Oximeter 360

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

Disclaimer: MAUDE figures for Artificial Heart 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 Artificial Heart; 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.