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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 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 603 603
Migration or Expulsion of Device 128 128
Detachment of Device or Device Component 126 126
Entrapment of Device 74 74
Burst Container or Vessel 63 63
Break 56 56
Physical Resistance/Sticking 50 50
Leak/Splash 43 43
Display or Visual Feedback Problem 40 40
Compatibility Problem 30 30
Difficult to Remove 26 26
Premature Activation 23 23
Material Deformation 19 19
Packaging Problem 17 17
No Apparent Adverse Event 15 15
Unintended Movement 15 15
Labelling, Instructions for Use or Training Problem 14 14
Difficult to Advance 13 13
Separation Failure 13 13
Chemical Problem 13 13
Device Damaged by Another Device 10 10
Improper Chemical Reaction 5 5
Use of Device Problem 4 4
Fluid/Blood Leak 4 4
Expiration Date Error 3 3
Stretched 3 3
Malposition of Device 3 3
Device Dislodged or Dislocated 3 3
Component or Accessory Incompatibility 3 3
Positioning Problem 2 2
Product Quality Problem 2 2
Incomplete or Missing Packaging 2 2
Appropriate Term/Code Not Available 2 2
Material Integrity Problem 1 1
Material Puncture/Hole 1 1
Structural Problem 1 1
Infusion or Flow Problem 1 1
Material Rupture 1 1
Material Separation 1 1
Free or Unrestricted Flow 1 1
Sparking 1 1
Activation Failure 1 1
Unexpected Therapeutic Results 1 1
Inaccurate Information 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 340 340
Intracranial Hemorrhage 155 155
Foreign Body In Patient 144 144
Hemorrhage/Bleeding 90 90
Unspecified Nervous System Problem 82 82
Insufficient Information 61 61
Hematoma 59 59
Obstruction/Occlusion 58 58
Device Embedded In Tissue or Plaque 55 55
Stroke/CVA 52 52
Headache 52 52
Ischemia 48 48
Rupture 42 42
Fistula 38 38
No Known Impact Or Consequence To Patient 38 38
Convulsion/Seizure 36 36
Muscle Weakness 36 36
Swelling/ Edema 32 32
Perforation of Vessels 31 31
Cognitive Changes 29 29
Ischemia Stroke 28 28
Vascular Dissection 27 27
Thrombosis/Thrombus 26 26
Paresis 24 24
Dysphasia 24 24
Vasoconstriction 24 24
Unspecified Infection 23 23
Pain 22 22
Paralysis 22 22
Confusion/ Disorientation 22 22
Visual Disturbances 21 21
Nerve Damage 19 19
Pulmonary Embolism 15 15
Visual Impairment 14 14
Hydrocephalus 14 14
Bacterial Infection 14 14
Hemorrhagic Stroke 13 13
Embolism/Embolus 13 13
Abscess 12 12
Inflammation 12 12
Necrosis 12 12
Fever 11 11
Respiratory Failure 10 10
Blurred Vision 10 10
Cardiac Arrest 10 10
Failure of Implant 10 10
Cyst(s) 9 9
High Blood Pressure/ Hypertension 9 9
Thromboembolism 9 9
Nausea 9 9

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