2026 data FDA MAUDE openFDA

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.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

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

#87 of 1000 · 38,070 reports · 2016–2026

  • BOOK 38,070 reports
  • RANK #87 of 1000
  • DEATH 4,677 death-typed
  • INJ 19,225 injury-typed
  • MALF 14,167 malfunction
  • SPAN 2016–2026
  • PEAK 2024: 18,592
  • PHOTO Introducer, Catheter

Nearest event-volume peer: Introducer, Catheter (37 report gap)

Temporary Non-Roller Type Left Heart Support Blood Pump sits #87 of 1000 among tracked device types with 38,070 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 →

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 12.3% corpus 1.5% · above corpus mean (+10.8 pp)
  • INJ 50.5% corpus 30.4% · above corpus mean (+20.1 pp)
  • MALF 37.2% corpus 64.5% · below corpus mean (-27.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 46% of coded problems · Lead manufacturer ABIOMED, INC. accounts for 87% of manufacturer-tagged reports · Top event location is 96% 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 38,070 MAUDE reports, ranked #87 of 1000.

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

Event Types

Injury 19,225 (50.5%)
Malfunction 14,167 (37.2%)
Death 4,677 (12.3%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 18,186 (43.0%)
13,909 (32.9%)
Death 3,237 (7.7%)
R 2,082 (4.9%)
D 1,432 (3.4%)
Other 1,142 (2.7%)
L 684 (1.6%)
Life Threatening 637 (1.5%)
Hospitalization 391 (0.9%)
O 271 (0.6%)
S 113 (0.3%)
H 102 (0.2%)
Disability 90 (0.2%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 17,859
Restricted Flow rate 2,707
Device Sensing Problem 2,348
Patient-Device Incompatibility 2,039
Pumping Stopped 1,610
Positioning Failure 1,474
Failure to Advance 1,356
Application Program Problem 1,270
Increase in Pressure 1,162
Malposition of Device 1,135
Fluid/Blood Leak 878
Patient Device Interaction Problem 857
Deformation Due to Compressive Stress 781
Battery Problem 627
Activation, Positioning or Separation Problem 606
Failure to Read Input Signal 600
Improper Flow or Infusion 492
Positioning Problem 492
Difficult to Insert 301
Difficult to Advance 299

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: 9,878
26
2026: 3,725

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

Event Locations

36,668 (96.3%)
I 1,263 (3.3%)
HOSPITAL 119 (0.3%)
NO INFORMATION 19 (0.0%)
OTHER 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Temporary Non-Roller Type Left Heart Suppor…, 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 (38,070 here).

Similar death-typed counts

Nearest other device types by death-typed report count (4,677 here), distinct from the volume row.

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.