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2026 data FDA MAUDE openFDA FDA Class II

Balloon Aortic Valvuloplasty

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 II (moderate risk, special controls required), regulated under 21 CFR §870.1255 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Balloon Aortic Valvuloplasty LIGHT-BOOK · MAUDE

#997 of 1000 · 367 reports · 2013–2026

  • BOOK 367 reports
  • RANK #997 of 1000
  • DEATH 35 death-typed
  • INJ 102 injury-typed
  • MALF 227 malfunction
  • SPAN 2013–2026
  • PEAK 2023: 47
  • PHOTO Microscope

Nearest event-volume peer: Microscope, Operating & Accessories, Ac-Powered, Ophthalmic (1 report gap)

Balloon Aortic Valvuloplasty sits #997 of 1000 among tracked device types with 367 MAUDE reports spanning 2013–2026. 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 →

Death-coded reports run above the device-type norm

Balloon Aortic Valvuloplasty carries 9.5% DEATH-coded reports, 8.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 9.5% corpus 1.5% · above corpus mean (+8.0 pp)
  • INJ 27.8% corpus 30.3% · below corpus mean (-2.5 pp)
  • MALF 61.9% corpus 64.8% · below corpus mean (-3.0 pp)

Lead product-problem code Material Rupture is 20% of coded problems · Lead manufacturer BARD PERIPHERAL VASCULAR, INC. accounts for 81% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Balloon Aortic Valvuloplasty in the event-volume neighbourhood

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

reports

What this shows Balloon Aortic Valvuloplasty carries 367 MAUDE reports, ranked #997 of 1000.

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

Event Types

Malfunction 227 (61.9%)
Injury 102 (27.8%)
Death 35 (9.5%)
Other 2 (0.5%)
1 (0.3%)

Patient Outcomes

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

245 (65.5%)
Required Intervention 66 (17.6%)
Death 22 (5.9%)
Other 22 (5.9%)
R 8 (2.1%)
Life Threatening 6 (1.6%)
D 4 (1.1%)
Hospitalization 1 (0.3%)

Top Product Problems

Material Rupture 87
Adverse Event Without Identified Device or Use Problem 64
Retraction Problem 46
Leak/Splash 33
Deflation Problem 30
Difficult to Remove 29
Inflation Problem 19
Break 17
Aspiration Issue 16
Detachment of Device or Device Component 16
Improper or Incorrect Procedure or Method 11
Insufficient Device Problem Information 10
Peeled/Delaminated 8
Burst Container or Vessel 7
Device-Device Incompatibility 7
Material Deformation 7
Packaging Problem 7
Device Operates Differently Than Expected 6
Difficult to Insert 5
Entrapment of Device 5

Yearly Trend

13
2013: 29
14
2014: 17
15
2015: 16
16
2016: 9
17
2017: 38
18
2018: 31
19
2019: 10
20
2020: 11
21
2021: 18
22
2022: 33
23
2023: 47
24
2024: 38
25
2025: 34
26
2026: 36

Reports in 2025 (34) held close to the prior two-year average of 43.

Related Entities for Balloon Aortic Valvuloplasty

Top Manufacturers

BARD PERIPHERAL VASCULAR, INC. 231
EDWARDS LIFESCIENCES 39
EDWARDS LIFESCIENCES LLC 10
Bard Peripheral Vascular, Inc. 5

Event Locations

229 (62.4%)
I 119 (32.4%)
HOSPITAL 14 (3.8%)
NO INFORMATION 5 (1.4%)

Compare BARD PERIPHERAL VASCULAR, INC. vs EDWARDS LIFESCIENCES →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Balloon Aortic Valvuloplasty: 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 (367 here).

Microscope 366 Light, Surgical, Accessories 369 Material, Impression 369 Antigens, All Groups, Streptococcus Spp. 370

Similar death-typed counts

Nearest other device types by death-typed report count (35 here), distinct from the volume row.

Adhesive 35 Electrocardiograph 35 Fluid Jet Removal System 35 Mattress, Flotation Therapy, Non-Powered 35

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

Disclaimer: MAUDE figures for Balloon Aortic Valvuloplasty 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 Balloon Aortic Valvuloplasty; 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.