Dialyzer, Capillary, Hollow Fiber
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 §876.5820 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Dialyzer, Capillary, Hollow Fiber LIGHT-BOOK · MAUDE
#238 of 1000 · 8,424 reports · 1992–2026
- BOOK 8,424 reports
- RANK #238 of 1000
- DEATH 157 death-typed
- INJ 3,168 injury-typed
- MALF 4,651 malfunction
- SPAN 1992–2026
- PEAK 1996: 1,522
- PHOTO Acid
Nearest event-volume peer: Acid, Hyaluronic, Intraarticular (14 report gap)
Dialyzer, Capillary, Hollow Fiber sits #238 of 1000 among tracked device types with 8,424 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 sit below the device-type norm
Dialyzer, Capillary, Hollow Fiber carries 55.2% MALFUNCTION-coded reports, 9.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.9% corpus 1.5% · near corpus mean (+0.4 pp)
- INJ 37.6% corpus 30.3% · above corpus mean (+7.3 pp)
- MALF 55.2% corpus 64.8% · below corpus mean (-9.6 pp)
Lead product-problem code Fluid/Blood Leak is 33% of coded problems · Lead manufacturer FRESENIUS MEDICAL CARE NORTH AMERICA accounts for 58% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .
Dialyzer, Capillary, Hollow Fiber in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Guide
Guide, Surgical, Instrument
8,485 reports
- Catheter
Catheter, Peripheral, Atherectomy
8,451 reports
- Dialyzer (this)
Dialyzer, Capillary, Hollow Fiber
8,424 reports
- Acid
Acid, Hyaluronic, Intraarticular
8,410 reports
- Abutment
Abutment, Implant, Dental, Endosseous
8,409 reports
- Hysteroscope
Hysteroscope (And Accessories)
8,394 reports
What this shows Dialyzer, Capillary, Hollow Fiber carries 8,424 MAUDE reports, ranked #238 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 rose to 145 in 2025, up from an average of 102 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Dialyzer, Capillary, Hollow Fiber
Top Manufacturers
Event Locations
Compare FRESENIUS MEDICAL CARE NORTH AMERICA vs BAXTER HEALTHCARE CORPORATION →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Dialyzer, Capillary, Hollow Fiber: 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 (8,424 here).
Similar death-typed counts
Nearest other device types by death-typed report count (157 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Dialyzer, Capillary, Hollow Fiber 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, Capillary, Hollow Fiber; 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.