What are FDA adverse event reports for Replacement Heart-Valve?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Replacement Heart-Valve, there are 36,406 total reports including 1,324 death reports and 33,785 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Replacement Heart-Valve?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Replacement Heart-Valve

Name: Replacement Heart-Valve - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

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

#93 of 1000 · 36,406 reports · 1992–2026

BOOK 36,406 reports
RANK #93 of 1000
DEATH 1,324 death-typed
INJ 33,785 injury-typed
MALF 1,215 malfunction
SPAN 1992–2026
PEAK 2023: 3,489
PHOTO Rod

Nearest event-volume peer: Rod, Fixation, Intramedullary And Accessories (101 report gap)

Replacement Heart-Valve sits #93 of 1000 among tracked device types with 36,406 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 3.6% corpus 1.5% · above corpus mean (+2.1 pp)
INJ 92.8% corpus 30.4% · above corpus mean (+62.4 pp)
MALF 3.3% corpus 64.5% · below corpus mean (-61.2 pp)

Lead product-problem code Insufficient Information is 29% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 82% of manufacturer-tagged reports · Top event location is 47% of location-tagged rows .

Insulin Pump…

37,844
Hexokinase

37,523
Device

37,213
Rod

36,507
Replacement H… (this)

36,406
Catheter

35,537

What this shows Replacement Heart-Valve carries 36,406 MAUDE reports, ranked #93 of 1000.

Event Types

Injury 33,785 (92.8%)

Death 1,324 (3.6%)

Malfunction 1,215 (3.3%)

74 (0.2%)

Other 8 (0.0%)

Patient Outcomes

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

R 22,450 (29.1%)

Hospitalization 18,882 (24.4%)

Required Intervention 10,391 (13.4%)

L 9,689 (12.5%)

H 8,102 (10.5%)

Life Threatening 3,717 (4.8%)

Death 1,415 (1.8%)

1,266 (1.6%)

Other 675 (0.9%)

O 548 (0.7%)

D 42 (0.1%)

S 41 (0.1%)

Disability 19 (0.0%)

Congenital Anomaly 12 (0.0%)

C 8 (0.0%)

Invalid Data 2 (0.0%)

Yearly Trend

1992: 22

1993: 6

1994: 4

1995: 3

1996: 3

1997: 33

1998: 10

1999: 8

2000: 16

2001: 5

2002: 6

2003: 5

2004: 19

2005: 10

2006: 23

2007: 19

2008: 16

2009: 910

2010: 1,071

2011: 1,221

2012: 1,015

2013: 1,219

2014: 1,282

2015: 1,242

2016: 1,744

2017: 2,284

2018: 3,166

2019: 2,820

2020: 2,466

2021: 2,833

2022: 2,566

2023: 3,489

2024: 3,435

2025: 3,156

2026: 279

Top Manufacturers

EDWARDS LIFESCIENCES 28,874

MEDTRONIC HEART VALVES DIVISION 5,218

EDWARDS LIFESCIENCES LLC 1,032

EDWARDS LIFESCIENCES, LLC 104

MEDTRONIC MEXICO 44

Event Locations

17,073 (46.9%)

I 15,102 (41.5%)

HOSPITAL 4,081 (11.2%)

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 similar MAUDE profiles

Two openFDA-derived peer sets for Replacement Heart-Valve, 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 (36,406 here).

Rod 36,507 Device, Impotence, Mechanical/Hydraulic 37,213 Catheter 35,537 Hexokinase, Glucose 37,523

Similar death-typed counts

Nearest other device types by death-typed report count (1,324 here), distinct from the volume row.

Introducer, Catheter 1,243 Pump, Infusion, Insulin 1,407 Mitral Valve Repair Devices 1,414 Automated Insulin Dosing Device System 1,227

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.

Replacement Heart-Valve

Event-type mix vs corpus