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2026 data FDA MAUDE openFDA FDA Class III

Temporary Non-Roller Type Left 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.

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FDA MAUDE casebook

openFDA event book Temporary Non-Roller Type Left Heart Suppor… MID-BOOK · MAUDE

#76 of 1000 · 44,306 reports · 2016–2026

  • BOOK 44,306 reports
  • RANK #76 of 1000
  • DEATH 5,667 death-typed
  • INJ 21,852 injury-typed
  • MALF 16,786 malfunction
  • SPAN 2016–2026
  • PEAK 2024: 18,592
  • PHOTO Powered Laser Surgica…

Nearest event-volume peer: Powered Laser Surgical Instrument (220 report gap)

Temporary Non-Roller Type Left Heart Support Blood Pump sits #76 of 1000 among tracked device types with 44,306 MAUDE reports spanning 2016–2026. 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 Left Heart Suppor… carries 37.9% MALFUNCTION-coded reports, 26.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 12.8% corpus 1.5% · above corpus mean (+11.3 pp)
  • INJ 49.3% corpus 30.3% · above corpus mean (+19.0 pp)
  • MALF 37.9% corpus 64.8% · below corpus mean (-26.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 42% of coded problems · Lead manufacturer ABIOMED, INC. accounts for 75% of manufacturer-tagged reports · Top event location is 97% of location-tagged rows .

Temporary Non-Roller Type Left Heart Suppor… 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 Left Heart Support Blood Pump carries 44,306 MAUDE reports, ranked #76 of 1000.

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

Event Types

Injury 21,852 (49.3%)
Malfunction 16,786 (37.9%)
Death 5,667 (12.8%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 20,377 (41.9%)
16,357 (33.7%)
Death 3,951 (8.1%)
R 2,365 (4.9%)
D 1,702 (3.5%)
Other 1,477 (3.0%)
L 700 (1.4%)
Life Threatening 656 (1.3%)
Hospitalization 392 (0.8%)
O 308 (0.6%)
S 116 (0.2%)
H 104 (0.2%)
Disability 91 (0.2%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 18,874
Restricted Flow rate 3,044
Device Sensing Problem 3,005
Patient Device Interaction Problem 2,611
Patient-Device Incompatibility 2,042
Pumping Stopped 1,768
Failure to Advance 1,654
Malposition of Device 1,633
Application Program Problem 1,498
Positioning Failure 1,486
Increase in Pressure 1,475
Fluid/Blood Leak 1,069
Deformation Due to Compressive Stress 967
Electrical /Electronic Property Problem 836
Failure to Read Input Signal 793
Battery Problem 699
Activation, Positioning or Separation Problem 606
Positioning Problem 493
Improper Flow or Infusion 492
Material Integrity Problem 421

Yearly Trend

16
2016: 18
17
2017: 109
18
2018: 149
19
2019: 300
20
2020: 341
21
2021: 567
22
2022: 542
23
2023: 3,849
24
2024: 18,592
25
2025: 9,882
26
2026: 9,957

Reports in 2025 (9,882) held close to the prior two-year average of 11,221.

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

Top Manufacturers

ABIOMED, INC. 32,605
ABIOMED, INC. - 1220648 8,887
ABIOMED, INC 1,096
ABIOMED INC. 576
Abiomed, Inc. - 1220648 310
ABIOMED. INC. 101

Event Locations

42,896 (96.8%)
I 1,263 (2.9%)
HOSPITAL 127 (0.3%)
NO INFORMATION 19 (0.0%)
OTHER 1 (0.0%)

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 Left Heart Suppor…: 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 (44,306 here).

Powered Laser Surgical Instrument 44,086 Stimulator, Spinal-Cord, Implanted 43,932 Dialyzer 43,552 Catheters 43,512

Similar death-typed counts

Nearest other device types by death-typed report count (5,667 here), distinct from the volume row.

Drug Eluting Permanent Right Ventricular Or… 5,055 Defibrillator 4,802 Ventilator, Non-Continuous 4,569 Automated External Defibrillators 4,510

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

Disclaimer: MAUDE figures for Temporary Non-Roller Type Left Heart Suppor… 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 Left Heart Suppor…; 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.