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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, embolectomy
Product CodeDXE
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIVI NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 770 770
2018 615 615
2019 594 594
2020 547 547
2021 333 333
2022 232 232

Device Problems MDRs with this Device Problem Events in those MDRs
Break 427 427
Material Deformation 391 391
Adverse Event Without Identified Device or Use Problem 261 261
Device Displays Incorrect Message 254 254
Material Rupture 246 246
Aspiration Issue 243 243
Physical Resistance/Sticking 217 217
Material Separation 150 150
Device Damaged Prior to Use 143 143
Deflation Problem 137 137
Detachment of Device or Device Component 129 129
Kinked 126 126
Suction Problem 107 107
Failure to Advance 104 104
Leak/Splash 104 104
Material Fragmentation 88 88
Physical Resistance 87 87
Display or Visual Feedback Problem 68 68
Entrapment of Device 55 55
Failure to Prime 55 55
Device Handling Problem 54 54
Out-Of-Box Failure 49 49
Device Operates Differently Than Expected 47 47
Inflation Problem 44 44
Collapse 42 42
Fluid Leak 39 39
Fracture 39 39
Detachment Of Device Component 37 37
Burst Container or Vessel 36 36
Difficult to Remove 35 35
Material Puncture/Hole 34 34
Stretched 34 34
Deformation Due to Compressive Stress 33 33
Device Difficult to Setup or Prepare 31 31
Material Twisted/Bent 30 30
Bent 22 22
Device Dislodged or Dislocated 21 21
Difficult to Advance 18 18
Defective Device 18 18
Material Perforation 17 17
Suction Failure 16 16
Material Disintegration 15 15
Hole In Material 15 15
Unraveled Material 15 15
Mechanical Problem 13 13
Crack 13 13
Appropriate Term/Code Not Available 13 13
Material Split, Cut or Torn 12 12
Pumping Problem 11 11
Mechanical Jam 11 11
Difficult to Insert 11 11
Decrease in Suction 10 10
Device Fell 10 10
Failure to Deflate 9 9
Material Integrity Problem 9 9
Pressure Problem 8 8
Component Missing 7 7
Retraction Problem 7 7
Separation Problem 7 7
Device Slipped 6 6
Use of Device Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Complete Blockage 6 6
Contamination 6 6
Torn Material 6 6
Device Damaged by Another Device 6 6
Device Contamination with Chemical or Other Material 5 5
Device Contamination with Body Fluid 5 5
Misconnection 5 5
Unexpected Shutdown 5 5
Migration 4 4
Material Frayed 4 4
Cut In Material 4 4
Defective Component 4 4
Unintended Movement 4 4
No Pressure 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Power Problem 3 3
Insufficient Information 3 3
Improper Flow or Infusion 3 3
Infusion or Flow Problem 3 3
Device Packaging Compromised 3 3
Nonstandard Device 3 3
Failure to Power Up 3 3
Unsealed Device Packaging 3 3
Migration or Expulsion of Device 2 2
Device Emits Odor 2 2
Off-Label Use 2 2
Shipping Damage or Problem 2 2
Device Stops Intermittently 2 2
Failure to Osseointegrate 2 2
Difficult to Flush 2 2
Corroded 2 2
Positioning Failure 2 2
Device Operational Issue 2 2
Protective Measures Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Osseointegration Problem 2 2
Incomplete or Missing Packaging 2 2
Failure to Deliver 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1634 1634
No Clinical Signs, Symptoms or Conditions 536 536
No Known Impact Or Consequence To Patient 324 324
No Patient Involvement 272 272
Device Embedded In Tissue or Plaque 101 101
Death 60 60
Foreign Body In Patient 57 58
Stroke/CVA 32 32
Insufficient Information 30 30
No Information 28 28
Embolism 23 23
Myocardial Infarction 22 22
Intracranial Hemorrhage 20 21
Renal Failure 20 20
Vascular Dissection 18 18
No Code Available 17 18
Patient Problem/Medical Problem 17 17
Low Blood Pressure/ Hypotension 17 17
Thrombus 16 16
Cardiac Tamponade 16 16
Hemoptysis 15 15
Bradycardia 15 15
Hemorrhage/Bleeding 14 14
Hemorrhage, Cerebral 13 13
Hemolysis 11 11
Infarction, Cerebral 10 11
Pain 10 10
Injury 10 10
Perforation of Vessels 9 9
Hemorrhage, Subarachnoid 9 9
Cardiac Arrest 9 9
Vessel Or Plaque, Device Embedded In 8 8
Pulmonary Embolism 8 8
Transient Ischemic Attack 8 8
Heart Failure 8 8
Blood Loss 8 8
Thromboembolism 7 7
Thrombosis/Thrombus 7 7
Vasoconstriction 7 7
Occlusion 7 7
Chest Pain 7 7
Hematoma 7 7
Thrombosis 6 6
High Blood Pressure/ Hypertension 6 6
Perforation 6 6
Stenosis 6 6
Loss of consciousness 5 5
Rupture 5 5
Cardiogenic Shock 5 5
Cardiac Perforation 5 5
Embolism/Embolus 5 5
Cardiopulmonary Arrest 5 5
Edema 4 4
Aneurysm 4 4
Tachycardia 4 4
Nausea 4 4
Pericardial Effusion 4 4
Chills 4 4
Vomiting 3 3
Discomfort 3 3
Inflammation 3 3
Ischemia 3 3
Ventricular Tachycardia 3 3
Anemia 3 3
Embolus 3 3
Fever 3 3
Headache 2 2
Cardiac Enzyme Elevation 2 2
Exsanguination 2 2
Extravasation 2 2
Arrhythmia 2 2
Air Embolism 2 2
Ventricular Fibrillation 2 2
Sepsis 2 2
Paresis 2 2
Laceration(s) 2 2
Hypoxia 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Ventilator Dependent 2 2
Obstruction/Occlusion 2 2
Multiple Organ Failure 2 2
Pseudoaneurysm 2 2
Heart Failure/Congestive Heart Failure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hydrocephalus 1 1
Foreign Body Embolism 1 1
Diminished Pulse Pressure 1 1
Hematuria 1 1
Vascular System (Circulation), Impaired 1 1
Alteration In Body Temperature 1 1
Test Result 1 1
Chest Tightness/Pressure 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Atrial Perforation 1 1
Collapse 1 1
Weakness 1 1
Convulsion, Clonic 1 1
Hemostasis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp I May-07-2020
2 Arrow International Inc I Nov-18-2021
3 Edwards Lifesciences, LLC II Aug-26-2017
4 INARI MEDICAL II Jun-09-2020
5 LeMaitre Vascular, Inc. I Apr-01-2020
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