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 · elevated Death-code · balanced

Volume signature

VANTIVE US HEALTHCARE LLC is a thinner MAUDE footprint

VANTIVE US HEALTHCARE LLC accounts for 5,893 FDA MAUDE reports (#340 of 434, thin-book tercile). Death-coded event_type share is 0.76% (elevated); Injury share 23.9% (balanced).

What the volume reading shows for VANTIVE US HEALTHCARE LLC

The standout signal for VANTIVE US HEALTHCARE LLC is filing volume: 5,893 adverse-event reports in FDA MAUDE (#340 of 434, thin-book). Death-coded event_type share sits at 0.76% (elevated).

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 4,441 (75.4% 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.

5,893
Total Reports
45
Event-type Death
1,407
Injury Reports
12
Device Types

Event Types

Malfunction 4,441 (75.4%)
Injury 1,407 (23.9%)
Death 45 (0.8%)

Patient Outcomes

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

4,210 (66.3%)
Required Intervention 733 (11.5%)
Hospitalization 444 (7.0%)
R 351 (5.5%)
H 306 (4.8%)
Other 240 (3.8%)
Death 32 (0.5%)
D 16 (0.3%)
O 16 (0.3%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Devices (12)

Device Reports
Set, Administration, For Peritoneal Dialysis, Disposable 2,862
Dialyzer, High Permeability With Or Without Sealed Dialysate System 1,626
System, Peritoneal, Automatic Delivery 1,078
Dialyzer, Capillary, Hollow Fiber 185
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma 65
Subsystem, Water Purification 52
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 13
Catheter, Hemodialysis, Non-Implanted 4
System, Hemodialysis, Remote Accessories 4
Hemodialyzer With Expanded Solute Removal Profile 2
Clamp, Line 1
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 1

Yearly Trend

24
2024: 4
25
2025: 3,634
26
2026: 2,255

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