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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device separator for therapeutic purposes, membrane automated blood cell/plasma
Product CodeMDP
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
4 5 3 4 2 0

MDR Year MDR Reports MDR Events
2021 10 10
2022 8 9
2023 16 16
2024 35 35
2025 54 54
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 90 91
Adverse Event Without Identified Device or Use Problem 25 25
Break 12 12
Crack 9 9
Biocompatibility 6 6
Detachment of Device or Device Component 4 4
Air/Gas in Device 3 3
Material Puncture/Hole 2 2
No Apparent Adverse Event 2 2
Material Split, Cut or Torn 1 1
Device Damaged Prior to Use 1 1
Insufficient Information 1 1
Unsealed Device Packaging 1 1
Obstruction of Flow 1 1
Material Twisted/Bent 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Device Contamination with Chemical or Other Material 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 100 101
Hypersensitivity/Allergic reaction 12 12
Low Blood Pressure/ Hypotension 6 6
Itching Sensation 3 3
Anaphylactic Shock 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Urticaria 2 2
Bradycardia 2 2
Tachycardia 2 2
Shock 2 2
Hemolysis 1 1
Vasodilatation 1 1
Anaphylactoid 1 1
Chest Pain 1 1
Dyspnea 1 1
Dehydration 1 1
Swelling/ Edema 1 1
Ischemia Stroke 1 1
Breast Discomfort/Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 VANTIVE US HEALTHCARE LLC II Feb-02-2026
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