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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.4100 (Cardiovascular panel).

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FDA MAUDE casebook

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

#981 of 1000 · 386 reports · 2021–2026

  • BOOK 386 reports
  • RANK #981 of 1000
  • DEATH 10 death-typed
  • INJ 74 injury-typed
  • MALF 302 malfunction
  • SPAN 2021–2026
  • PEAK 2025: 188
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Cholangiography (0 report gap)

Blood Pump For Ecmo, Long-Term (> 6 Hours) Use sits #981 of 1000 among tracked device types with 386 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 →

Malfunction reports run above the device-type norm

Blood Pump For Ecmo, Long-Term Use carries 78.2% MALFUNCTION-coded reports, 13.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.6% corpus 1.5% · above corpus mean (+1.1 pp)
  • INJ 19.2% corpus 30.3% · below corpus mean (-11.1 pp)
  • MALF 78.2% corpus 64.8% · above corpus mean (+13.4 pp)

Lead product-problem code Insufficient Device Problem Information is 21% of coded problems · Lead manufacturer THORATEC CORPORATION accounts for 96% 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 386 MAUDE reports, ranked #981 of 1000.

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

Event Types

Malfunction 302 (78.2%)
Injury 74 (19.2%)
Death 10 (2.6%)

Patient Outcomes

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

302 (71.6%)
Required Intervention 40 (9.5%)
Other 14 (3.3%)
Death 13 (3.1%)
H 12 (2.8%)
L 12 (2.8%)
R 9 (2.1%)
Life Threatening 9 (2.1%)
Hospitalization 6 (1.4%)
O 3 (0.7%)
D 2 (0.5%)

Top Product Problems

Insufficient Device Problem Information 108
Adverse Event Without Identified Device or Use Problem 58
Noise, Audible 46
Device Difficult to Setup or Prepare 44
Mechanical Problem 39
Unexpected Shutdown 39
Infusion or Flow Problem 35
No Apparent Adverse Event 28
Electrical /Electronic Property Problem 24
Device Alarm System 22
Pumping Stopped 15
Display or Visual Feedback Problem 13
Overheating of Device 11
Use of Device Problem 7
Fluid/Blood Leak 6
Excessive Heating 5
Obstruction of Flow 5
Communication or Transmission Problem 4
Failure to Interrogate 4
Product Quality Problem 4

Yearly Trend

21
2021: 1
23
2023: 5
24
2024: 134
25
2025: 188
26
2026: 58

Reports rose to 188 in 2025, up from an average of 70 in the two years before - a recent-year increase, not a lifetime pattern.

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

Top Manufacturers

THORATEC CORPORATION 23
MEDTRONIC MEXICO S. DE R.L. DE CV 1

Event Locations

386 (100.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Blood Pump For Ecmo, Long-Term Use: 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 (386 here).

Catheter, Cholangiography 386 Indicator 386 Scissors, Ophthalmic 385 Reagent Red Blood Cells 389

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Accessories, Catheter 10 Adaptor, Hygiene 10 Chair, Adjustable, Mechanical 10 Drape, Surgical, Antimicrobial 10

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.