2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#494 of 1000 · 1,948 reports · 2017–2026

  • BOOK 1,948 reports
  • RANK #494 of 1000
  • DEATH 336 death-typed
  • INJ 818 injury-typed
  • MALF 794 malfunction
  • SPAN 2017–2026
  • PEAK 2024: 1,031
  • PHOTO Trocar

Nearest event-volume peer: Trocar (1 report gap)

Temporary Non-Roller Type Right Heart Support Blood Pump sits #494 of 1000 among tracked device types with 1,948 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 →

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 17.2% corpus 1.5% · above corpus mean (+15.7 pp)
  • INJ 42.0% corpus 30.4% · above corpus mean (+11.6 pp)
  • MALF 40.8% corpus 64.5% · below corpus mean (-23.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 29% of coded problems · Lead manufacturer ABIOMED, INC. accounts for 83% 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 1,948 MAUDE reports, ranked #494 of 1000.

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

Event Types

Injury 818 (42.0%)
Malfunction 794 (40.8%)
Death 336 (17.2%)

Patient Outcomes

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

Required Intervention 789 (36.5%)
763 (35.3%)
Death 255 (11.8%)
R 103 (4.8%)
D 84 (3.9%)
Other 57 (2.6%)
L 34 (1.6%)
Life Threatening 30 (1.4%)
Hospitalization 16 (0.7%)
O 15 (0.7%)
S 13 (0.6%)
H 2 (0.1%)
Disability 2 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 628
Device Sensing Problem 334
Restricted Flow rate 302
Patient-Device Incompatibility 165
Increase in Pressure 123
Pumping Stopped 111
Failure to Advance 87
Positioning Failure 75
Patient Device Interaction Problem 56
Deformation Due to Compressive Stress 50
Application Program Problem 42
Improper Flow or Infusion 39
Malposition of Device 39
Failure to Sense 31
Fluid/Blood Leak 19
Defective Device 17
Material Twisted/Bent 17
Activation, Positioning or Separation Problem 16
Failure to Read Input Signal 15
Material Split, Cut or Torn 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: 554
26
2026: 225

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

Event Locations

1,909 (98.0%)
I 34 (1.7%)
HOSPITAL 3 (0.2%)
NO INFORMATION 2 (0.1%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Temporary Non-Roller Type Right Heart Suppo…, 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 (1,948 here).

Similar death-typed counts

Nearest other device types by death-typed report count (336 here), distinct from the volume row.

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.