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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agent, injectable, embolic
Product CodeMFE
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
4 3 1 1 5 0

MDR Year MDR Reports MDR Events
2020 124 124
2021 150 150
2022 176 176
2023 433 433
2024 248 248
2025 155 155

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 647 647
Detachment of Device or Device Component 147 147
Migration or Expulsion of Device 140 140
Entrapment of Device 83 83
Burst Container or Vessel 70 70
Break 63 63
Physical Resistance/Sticking 63 63
Leak/Splash 51 51
Display or Visual Feedback Problem 44 44
Compatibility Problem 34 34
Difficult to Remove 30 30
Premature Activation 23 23
Unintended Movement 23 23
Packaging Problem 23 23
Material Deformation 20 20
Difficult to Advance 18 18
No Apparent Adverse Event 16 16
Chemical Problem 15 15
Labelling, Instructions for Use or Training Problem 15 15
Separation Failure 14 14
Device Damaged by Another Device 11 11
Improper Chemical Reaction 6 6
Malposition of Device 5 5
Expiration Date Error 5 5
Use of Device Problem 5 5
Fluid/Blood Leak 4 4
Stretched 4 4
Product Quality Problem 4 4
Component or Accessory Incompatibility 3 3
Device Dislodged or Dislocated 3 3
Deformation Due to Compressive Stress 2 2
Appropriate Term/Code Not Available 2 2
Material Separation 2 2
Positioning Problem 2 2
Incomplete or Missing Packaging 2 2
Material Rupture 1 1
Free or Unrestricted Flow 1 1
Infusion or Flow Problem 1 1
Activation Failure 1 1
Structural Problem 1 1
Fracture 1 1
Excess Flow or Over-Infusion 1 1
Unexpected Therapeutic Results 1 1
Inaccurate Information 1 1
Material Integrity Problem 1 1
Material Puncture/Hole 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 387 387
Foreign Body In Patient 167 167
Intracranial Hemorrhage 166 166
Hemorrhage/Bleeding 98 98
Unspecified Nervous System Problem 82 82
Hematoma 69 69
Insufficient Information 62 62
Obstruction/Occlusion 62 62
Headache 56 56
Device Embedded In Tissue or Plaque 55 55
Stroke/CVA 54 54
Ischemia 54 54
Fistula 49 49
Rupture 43 43
Convulsion/Seizure 41 41
Ischemia Stroke 40 40
No Known Impact Or Consequence To Patient 38 38
Muscle Weakness 38 38
Swelling/ Edema 36 36
Cognitive Changes 34 34
Perforation of Vessels 33 33
Vasoconstriction 29 29
Thrombosis/Thrombus 28 28
Paralysis 28 28
Paresis 28 28
Vascular Dissection 27 27
Dysphasia 25 25
Unspecified Infection 24 24
Pain 24 24
Nerve Damage 23 23
Visual Disturbances 22 22
Confusion/ Disorientation 22 22
Hydrocephalus 17 17
Pulmonary Embolism 15 15
Bacterial Infection 15 15
Visual Impairment 14 14
Hemorrhagic Stroke 14 14
Abscess 13 13
Embolism/Embolus 13 13
Failure of Implant 13 13
Nervous System Injury 13 13
Inflammation 12 12
Necrosis 12 12
Pseudoaneurysm 11 11
Fever 11 11
Blurred Vision 10 10
Aneurysm 10 10
Cardiac Arrest 10 10
Thromboembolism 10 10
Respiratory Failure 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Micro Therapeutics, Inc. II Mar-04-2024
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