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2026 data FDA MAUDE openFDA FDA Class III

Temporary Non-Roller Type Right Heart Support Blood Pump

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 §870.4360 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Temporary Non-Roller Type Right Heart Suppo… LIGHT-BOOK · MAUDE

#479 of 1000 · 2,154 reports · 2017–2026

  • BOOK 2,154 reports
  • RANK #479 of 1000
  • DEATH 410 death-typed
  • INJ 914 injury-typed
  • MALF 830 malfunction
  • SPAN 2017–2026
  • PEAK 2024: 1,031
  • PHOTO Adaptor

Nearest event-volume peer: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (2 report gap)

Temporary Non-Roller Type Right Heart Support Blood Pump sits #479 of 1000 among tracked device types with 2,154 MAUDE reports spanning 2017–2026. 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 sit below the device-type norm

Temporary Non-Roller Type Right Heart Suppo… carries 38.5% MALFUNCTION-coded reports, 26.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 19.0% corpus 1.5% · above corpus mean (+17.5 pp)
  • INJ 42.4% corpus 30.3% · above corpus mean (+12.1 pp)
  • MALF 38.5% corpus 64.8% · below corpus mean (-26.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer ABIOMED, INC. accounts for 74% of manufacturer-tagged reports · Top event location is 98% of location-tagged rows .

Temporary Non-Roller Type Right Heart Suppo… in the event-volume neighbourhood

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

reports

What this shows Temporary Non-Roller Type Right Heart Support Blood Pump carries 2,154 MAUDE reports, ranked #479 of 1000.

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

Event Types

Injury 914 (42.4%)
Malfunction 830 (38.5%)
Death 410 (19.0%)

Patient Outcomes

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

Required Intervention 867 (36.7%)
775 (32.8%)
Death 314 (13.3%)
R 118 (5.0%)
D 103 (4.4%)
Other 66 (2.8%)
L 37 (1.6%)
Life Threatening 31 (1.3%)
O 16 (0.7%)
Hospitalization 16 (0.7%)
S 12 (0.5%)
H 3 (0.1%)
Disability 2 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 675
Device Sensing Problem 419
Restricted Flow rate 346
Patient-Device Incompatibility 166
Increase in Pressure 157
Patient Device Interaction Problem 127
Pumping Stopped 120
Failure to Advance 96
Positioning Failure 77
Malposition of Device 53
Deformation Due to Compressive Stress 52
Improper Flow or Infusion 39
Failure to Sense 31
Application Program Problem 22
Fluid/Blood Leak 21
Defective Device 17
Material Split, Cut or Torn 17
Material Twisted/Bent 17
Activation, Positioning or Separation Problem 16
Failure to Pump 15

Yearly Trend

17
2017: 2
18
2018: 10
19
2019: 10
20
2020: 10
21
2021: 7
22
2022: 9
23
2023: 90
24
2024: 1,031
25
2025: 551
26
2026: 434

Reports in 2025 (551) held close to the prior two-year average of 561.

Related Entities for Temporary Non-Roller Type Right Heart Support Blood Pump

Top Manufacturers

ABIOMED, INC. 1,580
ABIOMED, INC. - 1220648 389
ABIOMED. INC. 74
ABIOMED, INC 55
ABIOMED INC. 13
Abiomed, Inc. - 1220648 9
ABIOMED, INC. - 2

Event Locations

2,115 (98.2%)
I 34 (1.6%)
HOSPITAL 3 (0.1%)
NO INFORMATION 2 (0.1%)

Compare ABIOMED, INC. vs ABIOMED, INC. - 1220648 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Temporary Non-Roller Type Right Heart Suppo…: 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 (2,154 here).

Adaptor 2,152 Bottle, Collection, Vacuum 2,145 Catheter, Septostomy 2,144 Device, Irrigation, Ocular Surgery 2,143

Similar death-typed counts

Nearest other device types by death-typed report count (410 here), distinct from the volume row.

Prosthesis 415 Lift, Patient, Non-Ac-Powered 423 Ventilator, Continuous, Non-Life-Supporting 392 Prosthesis, Hip, Semi-Constrained 387

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

Disclaimer: MAUDE figures for Temporary Non-Roller Type Right Heart Suppo… 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 Temporary Non-Roller Type Right Heart Suppo…; 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.