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2026 data FDA MAUDE openFDA

Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

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.

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FDA MAUDE casebook

openFDA event book Blood Pump For Ecmo, Long-Term Use LIGHT-BOOK · MAUDE

#999 of 1000 · 345 reports · 2021–2026

  • BOOK 345 reports
  • RANK #999 of 1000
  • DEATH 12 death-typed
  • INJ 62 injury-typed
  • MALF 271 malfunction
  • SPAN 2021–2026
  • PEAK 2025: 187
  • PHOTO Gram Negative Identif…

Nearest event-volume peer: Gram Negative Identification Panel (2 report gap)

Blood Pump For Ecmo, Long-Term (> 6 Hours) Use sits #999 of 1000 among tracked device types with 345 MAUDE reports spanning 2021–2026. 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 3.5% corpus 1.5% · above corpus mean (+2.0 pp)
  • INJ 18.0% corpus 30.4% · below corpus mean (-12.5 pp)
  • MALF 78.6% corpus 64.5% · above corpus mean (+14.0 pp)

Lead product-problem code Insufficient Information is 21% of coded problems · Lead manufacturer THORATEC CORPORATION accounts for 95% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Blood Pump For Ecmo, Long-Term Use in the event-volume neighbourhood

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

reports

What this shows Blood Pump For Ecmo, Long-Term (> 6 Hours) Use carries 345 MAUDE reports, ranked #999 of 1000.

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

Event Types

Malfunction 271 (78.6%)
Injury 62 (18.0%)
Death 12 (3.5%)

Patient Outcomes

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

272 (72.3%)
Required Intervention 27 (7.2%)
Other 15 (4.0%)
Death 13 (3.5%)
H 11 (2.9%)
L 10 (2.7%)
R 9 (2.4%)
Life Threatening 9 (2.4%)
Hospitalization 6 (1.6%)
D 2 (0.5%)
O 2 (0.5%)

Top Product Problems

Insufficient Information 97
Adverse Event Without Identified Device or Use Problem 55
Noise, Audible 45
Device Difficult to Setup or Prepare 38
Unexpected Shutdown 37
Infusion or Flow Problem 33
Mechanical Problem 29
No Apparent Adverse Event 23
Electrical /Electronic Property Problem 22
Device Alarm System 20
Pumping Stopped 15
Display or Visual Feedback Problem 13
Overheating of Device 7
Fluid/Blood Leak 6
Use of Device Problem 5
Excessive Heating 4
Product Quality Problem 4
Communication or Transmission Problem 3
Failure to Interrogate 3
Power Problem 3

Yearly Trend

21
2021: 1
23
2023: 5
24
2024: 134
25
2025: 187
26
2026: 18

Related Entities for Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

Top Manufacturers

THORATEC CORPORATION 18
MEDTRONIC MEXICO S. DE R.L. DE CV 1

Event Locations

345 (100.0%)

Compare THORATEC CORPORATION vs MEDTRONIC MEXICO S. DE R.L. DE CV →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Blood Pump For Ecmo, Long-Term Use, 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 (345 here).

Gram Negative Identification Panel 343 Light, Surgical, Accessories 347 Stimulator, Carotid Sinus Nerve 347 Temporary Catheter 347

Similar death-typed counts

Nearest other device types by death-typed report count (12 here), distinct from the volume row.

Adhesive 12 Catheter, Retention Type, Balloon 12 Digital Breast Tomosynthesis 12 Implant, Dermal, For Aesthetic Use 12

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

Disclaimer: MAUDE figures for Blood Pump For Ecmo, Long-Term Use 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 Blood Pump For Ecmo, Long-Term Use; 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.