Dialyzer, High Permeability With Or Without Sealed Dialysate System
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 §876.5860 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Dialyzer MID-BOOK · MAUDE
#79 of 1000 · 43,552 reports · 1992–2026
- BOOK 43,552 reports
- RANK #79 of 1000
- DEATH 2,583 death-typed
- INJ 12,209 injury-typed
- MALF 28,079 malfunction
- SPAN 1992–2026
- PEAK 2014: 6,154
- PHOTO Catheters
Nearest event-volume peer: Catheters, Transluminal Coronary Angioplasty, Percutaneous (40 report gap)
Dialyzer, High Permeability With Or Without Sealed Dialysate System sits #79 of 1000 among tracked device types with 43,552 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 →
Death-coded reports run above the device-type norm
Dialyzer carries 5.9% DEATH-coded reports, 4.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 5.9% corpus 1.5% · above corpus mean (+4.4 pp)
- INJ 28.0% corpus 30.3% · below corpus mean (-2.3 pp)
- MALF 64.5% corpus 64.8% · near corpus mean (-0.4 pp)
Lead product-problem code Fluid/Blood Leak is 33% of coded problems · Lead manufacturer BAXTER HEALTHCARE - CLEVELAND accounts for 28% of manufacturer-tagged reports · Top event location is 74% of location-tagged rows .
Dialyzer in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Temporary Non…
Temporary Non-Roller Type Left Heart Support Blood Pump
44,306 reports
- Powered Laser…
Powered Laser Surgical Instrument
44,086 reports
- Stimulator
Stimulator, Spinal-Cord, Implanted (Pain Relief)
43,932 reports
- Dialyzer (this)
Dialyzer, High Permeability With Or Without Sealed Dialysate System
43,552 reports
- Catheters
Catheters, Transluminal Coronary Angioplasty, Percutaneous
43,512 reports
- Neurological…
Neurological Stereotaxic Instrument
42,726 reports
What this shows Dialyzer, High Permeability With Or Without Sealed Dialysate System carries 43,552 MAUDE reports, ranked #79 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 (2,822) held close to the prior two-year average of 2,567.
Related Entities for Dialyzer, High Permeability With Or Without Sealed Dialysate System
Top Manufacturers
Event Locations
Compare BAXTER HEALTHCARE - CLEVELAND vs BAXTER HEALTHCARE CORPORATION →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Dialyzer: 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 (43,552 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2,583 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Dialyzer 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 Dialyzer; 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.