Oxygenator, Cardiopulmonary Bypass
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 §870.4350 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Oxygenator, Cardiopulmonary Bypass MID-BOOK · MAUDE
#210 of 1000 · 10,612 reports · 1992–2026
- BOOK 10,612 reports
- RANK #210 of 1000
- DEATH 449 death-typed
- INJ 1,549 injury-typed
- MALF 8,284 malfunction
- SPAN 1992–2026
- PEAK 2026: 1,230
- PHOTO Cystoscope And Access…
Nearest event-volume peer: Cystoscope And Accessories, Flexible/Rigid (28 report gap)
Oxygenator, Cardiopulmonary Bypass sits #210 of 1000 among tracked device types with 10,612 MAUDE reports spanning 1992–2026. 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
Oxygenator, Cardiopulmonary Bypass carries 14.6% INJURY-coded reports, 15.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 4.2% corpus 1.5% · above corpus mean (+2.7 pp)
- INJ 14.6% corpus 30.3% · below corpus mean (-15.7 pp)
- MALF 78.1% corpus 64.8% · above corpus mean (+13.2 pp)
Lead product-problem code Fluid/Blood Leak is 27% of coded problems · Lead manufacturer PERFUSION SYSTEMS accounts for 28% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .
Oxygenator, Cardiopulmonary Bypass in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Ligator
Ligator, Esophageal
10,683 reports
- Walker
Walker, Mechanical
10,673 reports
- Cystoscope An…
Cystoscope And Accessories, Flexible/Rigid
10,640 reports
- Oxygenator (this)
Oxygenator, Cardiopulmonary Bypass
10,612 reports
- Stent
Stent, Superficial Femoral Artery
10,573 reports
- Appliance
Appliance, Fixation, Spinal Intervertebral Body
10,554 reports
What this shows Oxygenator, Cardiopulmonary Bypass carries 10,612 MAUDE reports, ranked #210 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 987 in 2025, up from an average of 637 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Oxygenator, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Compare PERFUSION SYSTEMS vs TERUMO CARDIOVASCULAR SYSTEMS CORPORATION →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Oxygenator, Cardiopulmonary Bypass: 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 (10,612 here).
Similar death-typed counts
Nearest other device types by death-typed report count (449 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Oxygenator, Cardiopulmonary Bypass 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 Oxygenator, Cardiopulmonary Bypass; 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.