PlainHospital

VANTIVE US HEALTHCARE LLC

Manufacturer adverse-event records for VANTIVE US HEALTHCARE LLC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2024–2026 · thin-book · typical Death-code · balanced

Volume signature

VANTIVE US HEALTHCARE LLC is a thinner MAUDE footprint

VANTIVE US HEALTHCARE LLC accounts for 4,332 FDA MAUDE reports (#391 of 443, thin-book tercile). Death-coded event_type share is 0.72% (typical); Injury share 22.8% (balanced).

What the volume reading shows for VANTIVE US HEALTHCARE LLC

The standout signal for VANTIVE US HEALTHCARE LLC is filing volume: 4,332 adverse-event reports in FDA MAUDE (#391 of 443, thin-book). Death-coded event_type share sits at 0.72% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 12 device types, led in this extract by Malfunction at 3,312 (76.5% of event_type total). Peak single-year volume reaches 3,634 reports across 3 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,332
Total Reports
31
Event-type Death
989
Injury Reports
12
Device Types

Event Types

Malfunction 3,312 (76.5%)
Injury 989 (22.8%)
Death 31 (0.7%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

3,250 (67.4%)
Required Intervention 565 (11.7%)
Hospitalization 315 (6.5%)
R 255 (5.3%)
H 235 (4.9%)
Other 150 (3.1%)
Death 25 (0.5%)
O 14 (0.3%)
D 11 (0.2%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Devices (12)

Device Reports
Set, Administration, For Peritoneal Dialysis, Disposable 2,178
Dialyzer, High Permeability With Or Without Sealed Dialysate System 1,143
System, Peritoneal, Automatic Delivery 765
Dialyzer, Capillary, Hollow Fiber 131
Subsystem, Water Purification 49
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma 47
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 9
Catheter, Hemodialysis, Non-Implanted 4
Hemodialyzer With Expanded Solute Removal Profile 2
System, Hemodialysis, Remote Accessories 2
Clamp, Line 1
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 1

Yearly Trend

24
2024: 4
25
2025: 3,634
26
2026: 694

Read our methodology - how this data is sourced, computed, and verified.