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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 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 27 27
Break 13 13
Use of Device Problem 11 11
Suction Problem 11 11
Material Separation 10 10
Mechanical Problem 6 6
Suction Failure 6 6
Defective Component 6 6
Therapeutic or Diagnostic Output Failure 5 5
Detachment of Device or Device Component 5 5
Decrease in Suction 4 7
Adverse Event Without Identified Device or Use Problem 4 4
Defective Device 3 3
Product Quality Problem 3 3
Pressure Problem 2 2
Leak/Splash 1 1
Device Slipped 1 1
Activation, Positioning or Separation Problem 1 1
Output Problem 1 1
Crack 1 1
Pumping Problem 1 1
Expiration Date Error 1 2
Material Integrity Problem 1 1
Material Rupture 1 1
Failure to Pump 1 1
Device Dislodged or Dislocated 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 42
Insufficient Information 25 26
Hematoma 9 9
Laceration(s) 9 10
Fetal Distress 8 8
Cephalohematoma 8 8
Pain 6 6
Distress 5 5
Hemorrhage/Bleeding 4 4
Encephalopathy 3 3
Anxiety 3 3
Bruise/Contusion 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Bone Fracture(s) 2 2
Abrasion 2 2
Intracranial Hemorrhage 2 2
Discomfort 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

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