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2026 data FDA MAUDE openFDA

Heart-Valve, Mechanical

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 Heart-Valve, Mechanical LIGHT-BOOK · MAUDE

#261 of 1000 · 6,889 reports · 1992–2026

  • BOOK 6,889 reports
  • RANK #261 of 1000
  • DEATH 883 death-typed
  • INJ 5,259 injury-typed
  • MALF 659 malfunction
  • SPAN 1992–2026
  • PEAK 2000: 513
  • PHOTO Laryngoscope, Rigid

Nearest event-volume peer: Laryngoscope, Rigid (23 report gap)

Heart-Valve, Mechanical sits #261 of 1000 among tracked device types with 6,889 MAUDE reports spanning 1992–2026. 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 12.8% corpus 1.5% · above corpus mean (+11.3 pp)
  • INJ 76.3% corpus 30.4% · above corpus mean (+45.9 pp)
  • MALF 9.6% corpus 64.5% · below corpus mean (-54.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 26% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC. accounts for 34% of manufacturer-tagged reports · Top event location is 37% of location-tagged rows .

Heart-Valve, Mechanical in the event-volume neighbourhood

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

reports

What this shows Heart-Valve, Mechanical carries 6,889 MAUDE reports, ranked #261 of 1000.

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

Event Types

Injury 5,259 (76.3%)
Death 883 (12.8%)
Malfunction 659 (9.6%)
Other 47 (0.7%)
41 (0.6%)

Patient Outcomes

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

Required Intervention 3,117 (31.6%)
R 1,757 (17.8%)
Hospitalization 1,695 (17.2%)
Death 875 (8.9%)
539 (5.5%)
L 461 (4.7%)
H 402 (4.1%)
Other 395 (4.0%)
O 274 (2.8%)
Life Threatening 239 (2.4%)
S 61 (0.6%)
D 28 (0.3%)
Disability 17 (0.2%)
Congenital Anomaly 9 (0.1%)
Invalid Data 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,001
Insufficient Information 875
Incomplete Coaptation 256
Perivalvular Leak 209
Physical Resistance/Sticking 205
Patient Device Interaction Problem 167
Fracture 158
Obstruction of Flow 151
Inadequacy of Device Shape and/or Size 125
Detachment of Device or Device Component 108
Gradient Increase 91
Biocompatibility 80
Appropriate Term/Code Not Available 78
Difficult to Open or Close 67
Patient-Device Incompatibility 61
Material Separation 56
Device Dislodged or Dislocated 52
Device Stenosis 46
Intravalvular regurgitation 41
Mechanical Jam 41

Yearly Trend

92
1992: 1
93
1993: 8
94
1994: 22
95
1995: 23
96
1996: 119
97
1997: 203
98
1998: 201
99
1999: 248
00
2000: 513
01
2001: 487
02
2002: 127
03
2003: 121
04
2004: 112
05
2005: 91
06
2006: 65
07
2007: 88
08
2008: 90
09
2009: 91
10
2010: 119
11
2011: 139
12
2012: 122
13
2013: 134
14
2014: 134
15
2015: 139
16
2016: 202
17
2017: 299
18
2018: 434
19
2019: 350
20
2020: 372
21
2021: 287
22
2022: 297
23
2023: 455
24
2024: 404
25
2025: 336
26
2026: 56

Related Entities for Heart-Valve, Mechanical

Top Manufacturers

ST. JUDE MEDICAL, INC. 833
ABBOTT MEDICAL 714
MEDTRONIC, INC. 692
MEDTRONIC HEART VALVES DIVISION 197

Event Locations

2,532 (36.8%)
HOSPITAL 2,233 (32.4%)
I 1,965 (28.5%)
UNKNOWN 43 (0.6%)
NO INFORMATION 39 (0.6%)
INVALID DATA 35 (0.5%)
HOME 23 (0.3%)
OTHER 7 (0.1%)
OUTPATIENT TREATMENT FACILITY 6 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.1%)
NOT APPLICABLE 1 (0.0%)

Compare ST. JUDE MEDICAL, INC. vs ABBOTT MEDICAL →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Heart-Valve, Mechanical, 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 (6,889 here).

Laryngoscope, Rigid 6,912 Prosthesis 6,864 Warmer, Thermal, Infusion Fluid 6,957 Hearing Aid, Bone Conduction 6,973

Similar death-typed counts

Nearest other device types by death-typed report count (883 here), distinct from the volume row.

Catheter, Thrombus Retriever 885 Wire, Guide, Catheter 895 Catheter, Percutaneous 869 Filter, Intravascular, Cardiovascular 928

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

Disclaimer: MAUDE figures for Heart-Valve, Mechanical 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 Heart-Valve, Mechanical; 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.