Catheter, Cannula And Tubing, Vascular, 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 §870.4210 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Catheter LIGHT-BOOK · MAUDE
#283 of 1000 · 6,232 reports · 1992–2026
- BOOK 6,232 reports
- RANK #283 of 1000
- DEATH 300 death-typed
- INJ 1,244 injury-typed
- MALF 4,539 malfunction
- SPAN 1992–2026
- PEAK 2025: 1,031
- PHOTO Device
Nearest event-volume peer: Device, Thermal Ablation, Endometrial (80 report gap)
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass sits #283 of 1000 among tracked device types with 6,232 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
Catheter carries 20.0% INJURY-coded reports, 10.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 4.8% corpus 1.5% · above corpus mean (+3.3 pp)
- INJ 20.0% corpus 30.3% · below corpus mean (-10.3 pp)
- MALF 72.8% corpus 64.8% · above corpus mean (+8.0 pp)
Lead product-problem code Material Separation is 13% of coded problems · Lead manufacturer PERFUSION SYSTEMS accounts for 36% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .
Catheter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Blood Culturing
6,354 reports
- Device
Device, Thermal Ablation, Endometrial
6,312 reports
- Catheter (this)
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
6,232 reports
- Prosthesis
Prosthesis, Intervertebral Disc
6,148 reports
- Suture
Suture, Nonabsorbable, Synthetic, Polyamide
6,091 reports
- Dislodger
Dislodger, Stone, Basket, Ureteral, Metal
6,079 reports
What this shows Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass carries 6,232 MAUDE reports, ranked #283 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 1,031 in 2025, up from an average of 436 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter: 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 (6,232 here).
Similar death-typed counts
Nearest other device types by death-typed report count (300 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter 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 Catheter; 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.