Accessories, Catheter
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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4200 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Accessories, Catheter LIGHT-BOOK · MAUDE
#698 of 1000 · 886 reports · 1992–2026
- BOOK 886 reports
- RANK #698 of 1000
- DEATH 10 death-typed
- INJ 122 injury-typed
- MALF 750 malfunction
- SPAN 1992–2026
- PEAK 2020: 113
- PHOTO Intrasaccular Flow Di…
Nearest event-volume peer: Intrasaccular Flow Disruption Device (3 report gap)
Accessories, Catheter sits #698 of 1000 among tracked device types with 886 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
Accessories, Catheter carries 84.7% MALFUNCTION-coded reports, 19.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
- INJ 13.8% corpus 30.3% · below corpus mean (-16.5 pp)
- MALF 84.7% corpus 64.8% · above corpus mean (+19.8 pp)
Lead product-problem code Fluid/Blood Leak is 19% of coded problems · Lead manufacturer COOK INC accounts for 54% of manufacturer-tagged reports · Top event location I is 47% of location-tagged rows .
Accessories, Catheter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Laparoscopic…
Laparoscopic Contraceptive Tubal Occlusion Device
893 reports
- Unit
Unit, Cautery, Thermal, Ac-Powered
893 reports
- Intrasaccular…
Intrasaccular Flow Disruption Device
889 reports
- Accessories (this)
Accessories, Catheter
886 reports
- Culture Media
Culture Media, Non-Selective And Non-Differential
879 reports
- Graft
Graft, Vascular, Synthetic/Biologic Composite
878 reports
What this shows Accessories, Catheter carries 886 MAUDE reports, ranked #698 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 31 in 2025, down from an average of 50 in the two years before.
Related Entities for Accessories, Catheter
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Accessories, 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 (886 here).
Similar death-typed counts
Nearest other device types by death-typed report count (10 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Accessories, 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 Accessories, 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.