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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 1 2 1 1 2 2 3 5 4 3 1 1 2

MDR Year MDR Reports MDR Events
2014 73 73
2015 238 238
2016 221 221
2017 365 365
2018 119 119
2019 119 119
2020 124 124
2021 150 150
2022 176 176
2023 433 433
2024 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1154 1154
Migration or Expulsion of Device 238 238
Detachment of Device or Device Component 122 122
Entrapment of Device 118 118
Burst Container or Vessel 91 91
Leak/Splash 69 69
Break 68 68
Detachment Of Device Component 40 40
Physical Resistance/Sticking 39 39
Display or Visual Feedback Problem 37 37
Difficult to Remove 33 33
Device Operates Differently Than Expected 28 28
Premature Activation 26 26
Compatibility Problem 24 24
No Apparent Adverse Event 17 17
Device Damaged by Another Device 16 16
Material Deformation 16 16
Material Rupture 16 16
Separation Failure 15 15
Packaging Problem 15 15
Material Separation 15 15
Component or Accessory Incompatibility 14 14
Labelling, Instructions for Use or Training Problem 14 14
Insufficient Information 12 12
Difficult to Advance 11 11
Unintended Movement 11 11
Use of Device Problem 11 11
Chemical Problem 10 10
Appropriate Term/Code Not Available 9 9
Reflux within Device 7 7
Improper Chemical Reaction 7 7
Occlusion Within Device 6 6
Physical Resistance 5 5
Structural Problem 4 4
Premature Separation 4 4
Malposition of Device 3 3
Therapy Delivered to Incorrect Body Area 3 3
Fluid/Blood Leak 3 3
Incomplete or Missing Packaging 3 3
Expiration Date Error 3 3
Coagulation in Device or Device Ingredient 3 3
Device Dislodged or Dislocated 3 3
Fracture 3 3
Patient-Device Incompatibility 3 3
Failure to Deliver 3 3
Product Quality Problem 2 2
Increase in Pressure 2 2
Optical Problem 2 2
Sticking 2 2
Positioning Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 355 355
No Clinical Signs, Symptoms or Conditions 287 287
Foreign Body In Patient 205 205
Intracranial Hemorrhage 204 204
Neurological Deficit/Dysfunction 154 154
Hemorrhage/Bleeding 119 119
Device Embedded In Tissue or Plaque 81 81
Unspecified Nervous System Problem 79 79
Paresis 66 66
Headache 65 65
Ischemia 63 63
Infarction, Cerebral 63 63
Hematoma 61 61
Therapeutic Response, Decreased 59 59
Insufficient Information 57 57
Death 56 56
Occlusion 55 55
Stroke/CVA 54 54
Obstruction/Occlusion 46 46
Unspecified Infection 42 42
Paralysis 41 41
Visual Impairment 39 39
Arrhythmia 38 38
Vasoconstriction 37 37
Perforation of Vessels 34 34
Nerve Damage 32 32
Rupture 31 31
Muscle Weakness 30 30
Pain 30 30
Hemorrhage, Subarachnoid 28 28
Swelling/ Edema 27 27
Convulsion/Seizure 27 27
Cognitive Changes 26 26
Fistula 25 25
Dysphasia 25 25
Pulmonary Embolism 24 24
Edema 24 24
Necrosis 22 22
Loss of Vision 22 22
Vascular Dissection 20 20
Confusion/ Disorientation 20 20
Hemorrhage, Cerebral 19 19
No Consequences Or Impact To Patient 19 19
Visual Disturbances 18 18
Thrombosis/Thrombus 17 17
Hydrocephalus 16 16
Inflammation 16 16
Bacterial Infection 16 16
Facial Nerve Paralysis 16 16
Thrombosis 15 15

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