Catheter, Urethral
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 §876.5130 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Catheter, Urethral LIGHT-BOOK · MAUDE
#444 of 1000 · 2,601 reports · 1994–2026
- BOOK 2,601 reports
- RANK #444 of 1000
- DEATH 4 death-typed
- INJ 685 injury-typed
- MALF 1,905 malfunction
- SPAN 1994–2026
- PEAK 2024: 468
- PHOTO Catheter
Nearest event-volume peer: Catheter, Conduction, Anesthetic (4 report gap)
Catheter, Urethral sits #444 of 1000 among tracked device types with 2,601 MAUDE reports spanning 1994–2026. 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 →
Malfunction reports run above the device-type norm
Catheter, Urethral carries 73.2% MALFUNCTION-coded reports, 8.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 26.3% corpus 30.3% · below corpus mean (-4.0 pp)
- MALF 73.2% corpus 64.8% · above corpus mean (+8.4 pp)
Lead product-problem code Tear, Rip or Hole in Device Packaging is 17% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 48% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .
Catheter, Urethral in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
2,621 reports
- Cerclage
Cerclage, Fixation
2,614 reports
- Catheter
Catheter, Conduction, Anesthetic
2,605 reports
- Catheter (this)
Catheter, Urethral
2,601 reports
- Iliac Covered…
Iliac Covered Stent, Arterial
2,591 reports
- Integrated Co…
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
2,582 reports
What this shows Catheter, Urethral carries 2,601 MAUDE reports, ranked #444 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 (320) held close to the prior two-year average of 335.
Related Entities for Catheter, Urethral
Top Manufacturers
Event Locations
Compare C.R. BARD, INC. (COVINGTON) -1018233 vs COLOPLAST A/S →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Urethral: 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 (2,601 here).
Similar death-typed counts
Nearest other device types by death-typed report count (4 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter, Urethral 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, Urethral; 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.