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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)
2021 2022 2023 2024 2025 2026
3 1 1 5 0 1

MDR Year MDR Reports MDR Events
2021 150 150
2022 176 176
2023 433 433
2024 248 248
2025 177 177
2026 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 611 611
Detachment of Device or Device Component 154 154
Migration or Expulsion of Device 143 143
Burst Container or Vessel 74 74
Entrapment of Device 69 69
Physical Resistance/Sticking 66 66
Break 60 60
Leak/Splash 47 47
Display or Visual Feedback Problem 38 38
Compatibility Problem 31 31
Unintended Movement 29 29
Difficult to Remove 27 27
Packaging Problem 26 26
Material Deformation 25 25
Difficult to Advance 20 20
No Apparent Adverse Event 16 16
Chemical Problem 14 14
Premature Activation 14 14
Separation Failure 9 9
Device Damaged by Another Device 8 8
Expiration Date Error 7 7
Labelling, Instructions for Use or Training Problem 7 7
Use of Device Problem 6 6
Malposition of Device 5 5
Product Quality Problem 4 4
Improper Chemical Reaction 4 4
Fluid/Blood Leak 4 4
Stretched 3 3
Device Dislodged or Dislocated 3 3
Inaccurate Information 3 3
Material Rupture 2 2
Incomplete or Missing Packaging 2 2
Material Separation 2 2
Appropriate Term/Code Not Available 2 2
Deformation Due to Compressive Stress 2 2
Material Puncture/Hole 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Excess Flow or Over-Infusion 1 1
Sparking 1 1
Retraction Problem 1 1
Free or Unrestricted Flow 1 1
Fracture 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 408 408
Foreign Body In Patient 176 176
Intracranial Hemorrhage 148 148
Hemorrhage/Bleeding 98 98
Unspecified Nervous System Problem 81 81
Hematoma 65 65
Insufficient Information 62 62
Obstruction/Occlusion 61 61
Headache 54 54
Ischemia 53 53
Stroke/CVA 53 53
Fistula 49 49
Ischemia Stroke 46 46
Convulsion/Seizure 41 41
Rupture 40 40
Device Embedded In Tissue or Plaque 39 39
Muscle Weakness 38 38
Swelling/ Edema 37 37
Cognitive Changes 34 34
Vasoconstriction 29 29
Paralysis 29 29
Thrombosis/Thrombus 28 28
Paresis 26 26
Dysphasia 25 25
Vascular Dissection 25 25
Pain 24 24
Nerve Damage 22 22
Confusion/ Disorientation 22 22
Visual Disturbances 22 22
Unspecified Infection 20 20
Perforation of Vessels 20 20
Pulmonary Embolism 15 15
Hydrocephalus 15 15
Bacterial Infection 15 15
Nervous System Injury 14 14
Embolism/Embolus 14 14
Failure of Implant 13 13
Visual Impairment 13 13
Hemorrhagic Stroke 13 13
Necrosis 12 12
Abscess 11 11
Pseudoaneurysm 11 11
Thromboembolism 10 10
Aneurysm 10 10
Blurred Vision 10 10
Inflammation 9 9
Cyst(s) 9 9
Cardiac Arrest 9 9
Numbness 9 9
Paraplegia 9 9

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