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2026 data FDA MAUDE openFDA FDA Class II

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

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 Extracorporeal System For Long-Term Respira… LIGHT-BOOK · MAUDE

#887 of 1000 · 505 reports · 2020–2026

  • BOOK 505 reports
  • RANK #887 of 1000
  • DEATH 27 death-typed
  • INJ 41 injury-typed
  • MALF 437 malfunction
  • SPAN 2020–2026
  • PEAK 2025: 131
  • PHOTO Bone Grafting Material

Nearest event-volume peer: Bone Grafting Material, Synthetic (0 report gap)

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure sits #887 of 1000 among tracked device types with 505 MAUDE reports spanning 2020–2026. 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 →

Injury-coded reports sit below the device-type norm

Extracorporeal System For Long-Term Respira… carries 8.1% INJURY-coded reports, 22.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.3% corpus 1.5% · above corpus mean (+3.8 pp)
  • INJ 8.1% corpus 30.3% · below corpus mean (-22.2 pp)
  • MALF 86.5% corpus 64.8% · above corpus mean (+21.7 pp)

Lead product-problem code Fluid/Blood Leak is 24% of coded problems · Lead manufacturer MEDTRONIC MEXICO S. DE R.L. DE CV accounts for 91% of manufacturer-tagged reports · Top event location is 89% of location-tagged rows .

Extracorporeal System For Long-Term Respira… in the event-volume neighbourhood

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

reports

What this shows Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure carries 505 MAUDE reports, ranked #887 of 1000.

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

Event Types

Malfunction 437 (86.5%)
Injury 41 (8.1%)
Death 27 (5.3%)

Patient Outcomes

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

436 (83.8%)
Death 25 (4.8%)
Required Intervention 24 (4.6%)
Life Threatening 10 (1.9%)
R 8 (1.5%)
Other 8 (1.5%)
L 4 (0.8%)
D 2 (0.4%)
O 2 (0.4%)
H 1 (0.2%)

Top Product Problems

Fluid/Blood Leak 183
Insufficient Device Problem Information 95
Communication or Transmission Problem 90
Output Problem 74
Incorrect, Inadequate or Imprecise Result or Readings 71
Mechanical Problem 66
Leak/Splash 64
Adverse Event Without Identified Device or Use Problem 39
Protective Measures Problem 13
Device Alarm System 12
Obstruction of Flow 12
Infusion or Flow Problem 10
Material Integrity Problem 8
Electrical /Electronic Property Problem 7
Noise, Audible 7
Improper Flow or Infusion 6
Material Separation 6
Air/Gas in Device 5
Crack 5
No Flow 5

Yearly Trend

20
2020: 17
21
2021: 52
22
2022: 53
23
2023: 104
24
2024: 75
25
2025: 131
26
2026: 73

Reports rose to 131 in 2025, up from an average of 90 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Top Manufacturers

MEDTRONIC MEXICO S. DE R.L. DE CV 10
Medtronic Mexico S. De R.L. De CV 1

Event Locations

447 (88.5%)
I 51 (10.1%)
HOSPITAL 7 (1.4%)

Compare MEDTRONIC MEXICO S. DE R.L. DE CV vs Medtronic Mexico S. De R.L. De CV →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Extracorporeal System For Long-Term Respira…: 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 (505 here).

Bone Grafting Material, Synthetic 505 Gases Used Within Eye To Place Pressure On… 504 Stylet, Tracheal Tube 506 Infusor, Pressure, For I.V. Bags 508

Similar death-typed counts

Nearest other device types by death-typed report count (27 here), distinct from the volume row.

Agent 27 Biopsy Needle 27 Instrument, Biopsy 27 Stimulator 27

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

Disclaimer: MAUDE figures for Extracorporeal System For Long-Term Respira… 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 Extracorporeal System For Long-Term Respira…; 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.