Controller, Temperature, 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 §870.4250 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Controller LIGHT-BOOK · MAUDE
#228 of 1000 · 9,165 reports · 1996–2026
- BOOK 9,165 reports
- RANK #228 of 1000
- DEATH 204 death-typed
- INJ 627 injury-typed
- MALF 7,957 malfunction
- SPAN 1996–2026
- PEAK 2023: 928
- PHOTO Negative Pressure Wou…
Nearest event-volume peer: Negative Pressure Wound Therapy Powered Suction Pump (1 report gap)
Controller, Temperature, Cardiopulmonary Bypass sits #228 of 1000 among tracked device types with 9,165 MAUDE reports spanning 1996–2026. 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
Controller carries 6.8% INJURY-coded reports, 23.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
- INJ 6.8% corpus 30.3% · below corpus mean (-23.5 pp)
- MALF 86.8% corpus 64.8% · above corpus mean (+22.0 pp)
Lead product-problem code Microbial Contamination of Device is 43% of coded problems · Lead manufacturer LIVANOVA DEUTSCHLAND accounts for 61% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .
Controller in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
9,364 reports
- Catheter
Catheter, Retention Type, Balloon
9,331 reports
- Intervertebra…
Intervertebral Fusion Device With Bone Graft, Lumbar
9,183 reports
- Controller (this)
Controller, Temperature, Cardiopulmonary Bypass
9,165 reports
- Negative Pres…
Negative Pressure Wound Therapy Powered Suction Pump
9,164 reports
- Percutaneous…
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
8,981 reports
What this shows Controller, Temperature, Cardiopulmonary Bypass carries 9,165 MAUDE reports, ranked #228 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 (680) held close to the prior two-year average of 742.
Related Entities for Controller, Temperature, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Compare LIVANOVA DEUTSCHLAND vs TERUMO CARDIOVASCULAR SYSTEMS CORP. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Controller: 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 (9,165 here).
Similar death-typed counts
Nearest other device types by death-typed report count (204 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Controller 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 Controller; 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.