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2026 data FDA MAUDE openFDA FDA Class III

Replacement Heart-Valve

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 Class III (highest risk, premarket approval required), regulated under 21 CFR §870.3925 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Replacement Heart-Valve MID-BOOK · MAUDE

#94 of 1000 · 37,100 reports · 1992–2026

  • BOOK 37,100 reports
  • RANK #94 of 1000
  • DEATH 1,336 death-typed
  • INJ 34,393 injury-typed
  • MALF 1,288 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 3,489
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (297 report gap)

Replacement Heart-Valve sits #94 of 1000 among tracked device types with 37,100 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 →

Injury-coded reports run above the device-type norm

Replacement Heart-Valve carries 92.7% INJURY-coded reports, 62.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.6% corpus 1.5% · above corpus mean (+2.1 pp)
  • INJ 92.7% corpus 30.3% · above corpus mean (+62.4 pp)
  • MALF 3.5% corpus 64.8% · below corpus mean (-61.4 pp)

Lead product-problem code Insufficient Device Problem Information is 28% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 81% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Replacement Heart-Valve in the event-volume neighbourhood

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

reports

What this shows Replacement Heart-Valve carries 37,100 MAUDE reports, ranked #94 of 1000.

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

Event Types

Injury 34,393 (92.7%)
Death 1,336 (3.6%)
Malfunction 1,288 (3.5%)
74 (0.2%)
Other 9 (0.0%)

Patient Outcomes

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

R 22,641 (29.0%)
Hospitalization 19,000 (24.3%)
Required Intervention 10,539 (13.5%)
L 9,830 (12.6%)
H 8,305 (10.6%)
Life Threatening 3,806 (4.9%)
Death 1,421 (1.8%)
1,315 (1.7%)
Other 674 (0.9%)
O 548 (0.7%)
D 44 (0.1%)
S 41 (0.1%)
Disability 19 (0.0%)
Congenital Anomaly 12 (0.0%)
C 8 (0.0%)
Invalid Data 2 (0.0%)

Top Product Problems

Insufficient Device Problem Information 14,407
Gradient Increase 6,140
Calcified 5,220
Degraded 4,744
Adverse Event Without Identified Device or Use Problem 3,999
Appropriate Device Problem Term/Code Not Available 3,115
Device Stenosis 2,603
Fluid/Blood Leak 2,445
Incomplete Coaptation 1,744
Perivalvular Leak 1,573
Unknown (for use when the device problem is not known) 1,545
Patient Device Interaction Problem 1,297
Intravalvular regurgitation 1,165
Difficult to Open or Close 608
Inadequacy of Device Shape and/or Size 379
Structural Problem 307
Material Split, Cut or Torn 276
Deterioration of prosthesis 212
Patient-Device Incompatibility 183
Leak/Splash 182

Yearly Trend

92
1992: 22
93
1993: 6
94
1994: 4
95
1995: 3
96
1996: 3
97
1997: 33
98
1998: 10
99
1999: 8
00
2000: 16
01
2001: 5
02
2002: 6
03
2003: 5
04
2004: 19
05
2005: 10
06
2006: 23
07
2007: 19
08
2008: 16
09
2009: 910
10
2010: 1,071
11
2011: 1,221
12
2012: 1,015
13
2013: 1,219
14
2014: 1,282
15
2015: 1,242
16
2016: 1,744
17
2017: 2,284
18
2018: 3,166
19
2019: 2,820
20
2020: 2,466
21
2021: 2,833
22
2022: 2,566
23
2023: 3,489
24
2024: 3,435
25
2025: 3,156
26
2026: 973

Reports in 2025 (3,156) held close to the prior two-year average of 3,462.

Related Entities for Replacement Heart-Valve

Top Manufacturers

EDWARDS LIFESCIENCES 29,144
MEDTRONIC HEART VALVES DIVISION 5,524
EDWARDS LIFESCIENCES LLC 1,071
EDWARDS LIFESCIENCES, LLC 105
MEDTRONIC MEXICO S. DE R.L. DE CV 55

Event Locations

17,768 (47.9%)
I 15,100 (40.7%)
HOSPITAL 4,082 (11.0%)
OPERATING ROOM 58 (0.2%)
OTHER 47 (0.1%)
NO INFORMATION 14 (0.0%)
HOME 12 (0.0%)
UNKNOWN 6 (0.0%)
INVALID DATA 5 (0.0%)
CLINIC - WALK IN, OTHER 3 (0.0%)
PATIENT'S HOME 2 (0.0%)
HOSPICE 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare EDWARDS LIFESCIENCES vs MEDTRONIC HEART VALVES DIVISION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Replacement Heart-Valve: 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 (37,100 here).

Catheter 36,803 Rod 37,471 Hexokinase, Glucose 37,534 Insulin Pump Secondary Display 38,005

Similar death-typed counts

Nearest other device types by death-typed report count (1,336 here), distinct from the volume row.

Introducer, Catheter 1,345 Pump, Infusion, Insulin 1,411 Leadless Pacemaker 1,257 Automated Insulin Dosing Device System 1,254

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

Disclaimer: MAUDE figures for Replacement Heart-Valve 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 Replacement Heart-Valve; 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.