Catheter, Hemodialysis, Non-Implanted
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 §876.5540 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Catheter, Hemodialysis, Non-Implanted LIGHT-BOOK · MAUDE
#388 of 1000 · 3,199 reports · 1995–2026
- BOOK 3,199 reports
- RANK #388 of 1000
- DEATH 73 death-typed
- INJ 603 injury-typed
- MALF 2,427 malfunction
- SPAN 1995–2026
- PEAK 2000: 285
- PHOTO System
Nearest event-volume peer: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer (9 report gap)
Catheter, Hemodialysis, Non-Implanted sits #388 of 1000 among tracked device types with 3,199 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 →
Injury-coded reports sit below the device-type norm
Catheter, Hemodialysis, Non-Implanted carries 18.8% INJURY-coded reports, 11.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
- INJ 18.8% corpus 30.3% · below corpus mean (-11.4 pp)
- MALF 75.9% corpus 64.8% · above corpus mean (+11.0 pp)
Lead product-problem code Crack is 17% of coded problems · Lead manufacturer COVIDIEN accounts for 30% of manufacturer-tagged reports · Top event location is 45% of location-tagged rows .
Catheter, Hemodialysis, Non-Implanted in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Stimulator
Stimulator, Electrical, Evoked Response
3,228 reports
- Integrated Co…
Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
3,214 reports
- System
System, Dialysate Delivery, Sealed
3,214 reports
- Catheter (this)
Catheter, Hemodialysis, Non-Implanted
3,199 reports
- System
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
3,190 reports
- Test
Test, Hiv Detection
3,187 reports
What this shows Catheter, Hemodialysis, Non-Implanted carries 3,199 MAUDE reports, ranked #388 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 (191) held close to the prior two-year average of 192.
Related Entities for Catheter, Hemodialysis, Non-Implanted
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Hemodialysis, Non-Implanted: 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 (3,199 here).
Similar death-typed counts
Nearest other device types by death-typed report count (73 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter, Hemodialysis, Non-Implanted 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, Hemodialysis, Non-Implanted; 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.