Accessories, Catheter, G-U
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 Accessories, Catheter, G-U LIGHT-BOOK · MAUDE
#977 of 1000 · 392 reports · 1995–2026
- BOOK 392 reports
- RANK #977 of 1000
- DEATH 2 death-typed
- INJ 99 injury-typed
- MALF 278 malfunction
- SPAN 1995–2026
- PEAK 2004: 61
- PHOTO Controller
Nearest event-volume peer: Controller, Foot, Handpiece And Cord (0 report gap)
Accessories, Catheter, G-U sits #977 of 1000 among tracked device types with 392 MAUDE reports spanning 1995–2026. 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
Accessories, Catheter, G-U carries 70.9% MALFUNCTION-coded reports, 6.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
- INJ 25.3% corpus 30.3% · below corpus mean (-5.0 pp)
- MALF 70.9% corpus 64.8% · above corpus mean (+6.1 pp)
Lead product-problem code Break is 26% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORP. accounts for 32% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .
Accessories, Catheter, G-U in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Alkaline Picr…
Alkaline Picrate, Colorimetry, Creatinine
394 reports
- Needle
Needle, Catheter
394 reports
- Perforator
Perforator, Ear-Lobe
393 reports
- Accessories (this)
Accessories, Catheter, G-U
392 reports
- Controller
Controller, Foot, Handpiece And Cord
392 reports
- Stool
Stool, Operating-Room
392 reports
What this shows Accessories, Catheter, G-U carries 392 MAUDE reports, ranked #977 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 fell to 3 in 2025, down from an average of 9 in the two years before.
Related Entities for Accessories, Catheter, G-U
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Accessories, Catheter, G-U: 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 (392 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Accessories, Catheter, G-U 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 Accessories, Catheter, G-U; 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.