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2025 data FDA MAUDE openFDA FDA Class III

Heart-Valve, Allograft

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, Allograft LIGHT-BOOK · MAUDE

#912 of 1000 · 474 reports · 1995–2025

  • BOOK 474 reports
  • RANK #912 of 1000
  • DEATH 36 death-typed
  • INJ 345 injury-typed
  • MALF 30 malfunction
  • SPAN 1995–2025
  • PEAK 2002: 72
  • PHOTO Microscope, Surgical

Nearest event-volume peer: Microscope, Surgical (1 report gap)

Heart-Valve, Allograft sits #912 of 1000 among tracked device types with 474 MAUDE reports spanning 1995–2025. 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 →

Malfunction reports sit below the device-type norm

Heart-Valve, Allograft carries 6.3% MALFUNCTION-coded reports, 58.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 7.6% corpus 1.5% · above corpus mean (+6.1 pp)
  • INJ 72.8% corpus 30.3% · above corpus mean (+42.5 pp)
  • MALF 6.3% corpus 64.8% · below corpus mean (-58.5 pp)

Lead product-problem code Explanted is 30% of coded problems · Top event location is 61% of location-tagged rows .

Heart-Valve, Allograft in the event-volume neighbourhood

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

reports

What this shows Heart-Valve, Allograft carries 474 MAUDE reports, ranked #912 of 1000.

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

Event Types

Injury 345 (72.8%)
Other 55 (11.6%)
Death 36 (7.6%)
Malfunction 30 (6.3%)
8 (1.7%)

Patient Outcomes

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

R 287 (27.6%)
Hospitalization 262 (25.2%)
L 236 (22.7%)
Other 100 (9.6%)
Required Intervention 45 (4.3%)
Death 37 (3.6%)
O 34 (3.3%)
16 (1.5%)
Life Threatening 15 (1.4%)
H 5 (0.5%)
S 1 (0.1%)

Top Product Problems

Explanted 216
Replace 128
Device remains implanted 48
Tears, rips, holes in device, device material 43
Calcified 42
Adverse Event Without Identified Device or Use Problem 32
Inadequacy of Device Shape and/or Size 23
Obstruction of Flow 23
Valve(s), failure of 22
Degraded 20
Unknown (for use when the device problem is not known) 20
Material Deformation 17
Microbial Contamination of Device 13
Insufficient Device Problem Information 12
Leak/Splash 12
Other (for use when an appropriate device code cannot be identified) 12
Crack 10
Occlusion Within Device 10
Repair 10
Contamination 9

Yearly Trend

95
1995: 2
96
1996: 18
97
1997: 61
98
1998: 60
99
1999: 33
00
2000: 13
01
2001: 23
02
2002: 72
03
2003: 31
04
2004: 20
05
2005: 11
06
2006: 9
08
2008: 6
09
2009: 3
10
2010: 13
11
2011: 18
12
2012: 6
13
2013: 2
14
2014: 2
15
2015: 25
16
2016: 15
17
2017: 1
18
2018: 2
19
2019: 4
20
2020: 3
21
2021: 4
22
2022: 5
23
2023: 4
24
2024: 3
25
2025: 5

Reports in 2024 (3) held close to the prior two-year average of 5.

Related Entities for Heart-Valve, Allograft

Event Locations

287 (60.5%)
HOSPITAL 120 (25.3%)
I 49 (10.3%)
UNKNOWN 8 (1.7%)
INVALID DATA 4 (0.8%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
HOME 1 (0.2%)
NO INFORMATION 1 (0.2%)
NOT APPLICABLE 1 (0.2%)
OTHER 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Heart-Valve, Allograft: 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 (474 here).

Microscope, Surgical 473 Nucleic-Acid Tests Used For Infectious Dise… 475 System, Identification, Hepatitis B Antigen 472 Agents 477

Similar death-typed counts

Nearest other device types by death-typed report count (36 here), distinct from the volume row.

Arthroscope 36 Compressor, Air, Portable 36 Dura Substitute 36 Adhesive 35

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

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