Console, Heart-Lung Machine, 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 §870.4220 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Console MID-BOOK · MAUDE
#157 of 1000 · 17,288 reports · 1992–2026
- BOOK 17,288 reports
- RANK #157 of 1000
- DEATH 264 death-typed
- INJ 444 injury-typed
- MALF 15,630 malfunction
- SPAN 1992–2026
- PEAK 2012: 1,626
- PHOTO Unit
Nearest event-volume peer: Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (91 report gap)
Console, Heart-Lung Machine, Cardiopulmonary Bypass sits #157 of 1000 among tracked device types with 17,288 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
Console carries 2.6% INJURY-coded reports, 27.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.5% corpus 1.5% · near corpus mean (+0.0 pp)
- INJ 2.6% corpus 30.3% · below corpus mean (-27.7 pp)
- MALF 90.4% corpus 64.8% · above corpus mean (+25.6 pp)
Lead product-problem code Device Displays Incorrect Message is 14% of coded problems · Lead manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORP. accounts for 41% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .
Console in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Unit
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
17,379 reports
- Console (this)
Console, Heart-Lung Machine, Cardiopulmonary Bypass
17,288 reports
- System
System, Appendage Closure, Left Atrial
17,177 reports
- Fastener
Fastener, Fixation, Biodegradable, Soft Tissue
17,071 reports
- Catheter
Catheter, Urological
17,035 reports
- Template
Template
16,915 reports
What this shows Console, Heart-Lung Machine, Cardiopulmonary Bypass carries 17,288 MAUDE reports, ranked #157 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 in 2025 (1,031) held close to the prior two-year average of 841.
Related Entities for Console, Heart-Lung Machine, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Compare TERUMO CARDIOVASCULAR SYSTEMS CORP. vs TERUMO CARDIOVASCULAR SYSTEMS CORPORATION →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Console: 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 (17,288 here).
Similar death-typed counts
Nearest other device types by death-typed report count (264 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Console 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 Console; 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.