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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extractor, vacuum, fetal
Regulation Description Fetal vacuum extractor.
Product CodeHDB
Regulation Number 884.4340
Device Class 2


Premarket Reviews
ManufacturerDecision
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 21 21
2022 12 13
2023 23 25
2024 24 24
2025 17 17
2026 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Device Problem Information 28 28
Use of Device Problem 8 8
Material Separation 8 8
Suction Problem 7 7
Mechanical Problem 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 43
Insufficient Information 27 28
Cephalohematoma 9 9
Hematoma 9 9
Laceration(s) 9 10
Fetal Distress 8 8
Pain 6 6
Distress 5 5
Hemorrhage/Blood Loss/Bleeding 4 4
Encephalopathy 3 3
Anxiety 3 3
Bruise/Contusion 3 3
Bone Fracture(s) 2 2
Abrasion 2 2
Intracranial Hemorrhage 2 2
Discomfort 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
No Code Available 1 1
Skull Fracture 1 1
Perinatal Brain Injury 1 1
Blister 1 1
Easy Bruising 1 1
Vaginal Mucosa Damage 1 1
Foreign Body In Patient 1 1
Hemorrhage, Subgaleal 1 1
Bradycardia 1 1
Swelling/ Edema 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Clinical Innovations, LLC II Apr-24-2026
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