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2026 data FDA MAUDE openFDA FDA Class I

Stabilizer, 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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §870.4500 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Stabilizer, Heart LIGHT-BOOK · MAUDE

#659 of 1000 · 1,025 reports · 2000–2026

  • BOOK 1,025 reports
  • RANK #659 of 1000
  • DEATH 6 death-typed
  • INJ 115 injury-typed
  • MALF 897 malfunction
  • SPAN 2000–2026
  • PEAK 2022: 98
  • PHOTO Restraint, Protective

Nearest event-volume peer: Restraint, Protective (2 report gap)

Stabilizer, Heart sits #659 of 1000 among tracked device types with 1,025 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 → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Stabilizer, Heart carries 87.5% MALFUNCTION-coded reports, 22.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 11.2% corpus 30.3% · below corpus mean (-19.1 pp)
  • MALF 87.5% corpus 64.8% · above corpus mean (+22.7 pp)

Lead product-problem code Break is 22% of coded problems · Lead manufacturer MAQUET CARDIOVASCULAR LLC accounts for 39% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Stabilizer, Heart in the event-volume neighbourhood

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

reports

What this shows Stabilizer, Heart carries 1,025 MAUDE reports, ranked #659 of 1000.

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

Event Types

Malfunction 897 (87.5%)
Injury 115 (11.2%)
Death 6 (0.6%)
Other 4 (0.4%)
3 (0.3%)

Patient Outcomes

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

860 (82.5%)
Required Intervention 103 (9.9%)
Other 39 (3.7%)
R 19 (1.8%)
Life Threatening 10 (1.0%)
Death 5 (0.5%)
Hospitalization 4 (0.4%)
H 1 (0.1%)
L 1 (0.1%)
O 1 (0.1%)

Top Product Problems

Break 206
Mechanical Problem 183
Detachment Of Device Component 75
Positioning Failure 63
Suction Problem 54
Component Missing 40
Device Operates Differently Than Expected 37
Positioning Problem 36
Replace 36
Loose or Intermittent Connection 29
Device Slipped 28
Mechanics Altered 21
Material Deformation 20
Detachment of Device or Device Component 18
Suction Failure 17
Component Falling 16
Component(s), broken 16
Adverse Event Without Identified Device or Use Problem 15
Fracture 15
Insufficient Device Problem Information 15

Yearly Trend

00
2000: 5
01
2001: 6
02
2002: 5
03
2003: 19
04
2004: 25
05
2005: 6
06
2006: 17
07
2007: 27
08
2008: 8
09
2009: 7
10
2010: 16
11
2011: 90
12
2012: 20
13
2013: 22
14
2014: 34
15
2015: 66
16
2016: 52
17
2017: 45
18
2018: 54
19
2019: 59
20
2020: 43
21
2021: 74
22
2022: 98
23
2023: 67
24
2024: 56
25
2025: 64
26
2026: 40

Reports in 2025 (64) held close to the prior two-year average of 62.

Related Entities for Stabilizer, Heart

Top Manufacturers

MAQUET CARDIOVASCULAR LLC 316
MAQUET CV 147
MAQUET CARDIOVASCULAR, LLC 87
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 80
GUIDANT CARDIAC SURGERY 71
PERFUSION SYSTEMS 65
TERUMO CARDIOVASCULAR SYSTEMS CORP. 39

Event Locations

535 (52.2%)
I 318 (31.0%)
HOSPITAL 145 (14.1%)
NO INFORMATION 10 (1.0%)
OTHER 10 (1.0%)
UNKNOWN 5 (0.5%)
INVALID DATA 1 (0.1%)
NOT APPLICABLE 1 (0.1%)

Compare MAQUET CARDIOVASCULAR LLC vs MAQUET CV →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stabilizer, 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 (1,025 here).

Restraint, Protective 1,027 Bath, Hydro-Massage 1,022 Motor 1,030 Blood Establishment Computer Software And A… 1,034

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Dilator, Catheter, Ureteral 6

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

Disclaimer: MAUDE figures for Stabilizer, 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 Stabilizer, 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.