Catheter, Urological
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, Urological MID-BOOK · MAUDE
#160 of 1000 · 17,035 reports · 1992–2026
- BOOK 17,035 reports
- RANK #160 of 1000
- DEATH 29 death-typed
- INJ 2,757 injury-typed
- MALF 13,851 malfunction
- SPAN 1992–2026
- PEAK 2017: 1,873
- PHOTO Fastener
Nearest event-volume peer: Fastener, Fixation, Biodegradable, Soft Tissue (36 report gap)
Catheter, Urological sits #160 of 1000 among tracked device types with 17,035 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 →
Malfunction reports run above the device-type norm
Catheter, Urological carries 81.3% MALFUNCTION-coded reports, 16.5pp 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 (-1.3 pp)
- INJ 16.2% corpus 30.3% · below corpus mean (-14.1 pp)
- MALF 81.3% corpus 64.8% · above corpus mean (+16.5 pp)
Lead product-problem code Deflation Problem is 11% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 80% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .
Catheter, Urological in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Console
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 (this)
Catheter, Urological
17,035 reports
- Template
Template
16,915 reports
- Laparoscope
Laparoscope, Gynecologic (And Accessories)
16,889 reports
What this shows Catheter, Urological carries 17,035 MAUDE reports, ranked #160 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 (1,419) held close to the prior two-year average of 1,210.
Related Entities for Catheter, Urological
Top Manufacturers
Event Locations
Compare C.R. BARD, INC. (COVINGTON) -1018233 vs C.R. BARD INC. (COVINGTON) -1018233 →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Urological: 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 (17,035 here).
Similar death-typed counts
Nearest other device types by death-typed report count (29 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter, Urological 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, Urological; 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.