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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
  SUBSTANTIALLY EQUIVALENT 3
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIVI NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 266 266
2016 795 795
2017 770 770
2018 615 615
2019 594 594
2020 547 547
2021 333 333
2022 463 463
2023 436 436
2024 262 262

Device Problems MDRs with this Device Problem Events in those MDRs
Break 692 692
Material Rupture 502 502
Aspiration Issue 488 488
Device Displays Incorrect Message 455 455
Material Deformation 452 452
Adverse Event Without Identified Device or Use Problem 410 410
Material Fragmentation 360 360
Kinked 230 230
Material Separation 229 229
Physical Resistance/Sticking 219 219
Deflation Problem 207 207
Detachment of Device or Device Component 189 189
Device Damaged Prior to Use 175 175
Leak/Splash 163 163
Suction Problem 140 140
Physical Resistance 126 126
Failure to Advance 124 124
Display or Visual Feedback Problem 110 110
Entrapment of Device 106 106
Detachment Of Device Component 85 85
Out-Of-Box Failure 75 75
Fracture 73 73
Device Operates Differently Than Expected 71 71
Device Handling Problem 70 70
Burst Container or Vessel 66 66
Failure to Prime 63 63
Difficult to Remove 56 56
Material Puncture/Hole 56 56
Stretched 54 54
Inflation Problem 54 54
Collapse 53 53
Device Difficult to Setup or Prepare 45 45
Failure to Deflate 43 43
Fluid/Blood Leak 43 43
Material Twisted/Bent 39 39
Deformation Due to Compressive Stress 37 37
Difficult to Advance 35 35
Bent 32 32
Material Disintegration 32 32
Defective Device 27 27
Hole In Material 27 27
Material Integrity Problem 26 26
Device Dislodged or Dislocated 25 25
Unraveled Material 25 25
Material Perforation 22 22
Pumping Problem 21 21
Difficult to Insert 21 21
Crack 20 20
Mechanical Problem 18 18
Appropriate Term/Code Not Available 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2383 2383
No Clinical Signs, Symptoms or Conditions 1371 1371
No Known Impact Or Consequence To Patient 428 428
No Patient Involvement 343 343
Device Embedded In Tissue or Plaque 132 132
Foreign Body In Patient 79 80
Death 77 77
Insufficient Information 53 53
Stroke/CVA 45 45
No Information 45 45
Low Blood Pressure/ Hypotension 35 35
No Code Available 32 33
Myocardial Infarction 30 30
Renal Failure 28 28
Hemorrhage/Bleeding 27 27
Vascular Dissection 26 26
Embolism 23 23
Intracranial Hemorrhage 23 24
Bradycardia 22 22
Thrombus 21 21
Cardiac Tamponade 20 20
Patient Problem/Medical Problem 19 19
Pulmonary Embolism 16 16
Hemoptysis 16 16
Hemorrhage, Subarachnoid 14 14
Infarction, Cerebral 14 15
Perforation 14 14
Hemorrhage, Cerebral 14 14
Embolism/Embolus 13 13
Blood Loss 13 13
Pain 13 13
Injury 12 12
Hemolysis 12 12
Stenosis 12 12
Thrombosis/Thrombus 11 11
Hematoma 11 11
Cardiac Arrest 11 11
Perforation of Vessels 11 11
Transient Ischemic Attack 10 10
Chest Pain 9 9
Tachycardia 9 9
Thromboembolism 9 9
Cardiopulmonary Arrest 8 8
Pericardial Effusion 8 8
Vessel Or Plaque, Device Embedded In 8 8
Heart Failure 8 8
Vasoconstriction 8 8
Ischemia 8 8
Occlusion 8 8
Laceration(s) 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp I May-07-2020
2 Arrow International Inc I Nov-18-2021
3 Arrow International Inc II Sep-30-2016
4 Boston Scientific Corporation I Apr-18-2016
5 Boston Scientific Corporation II Aug-13-2015
6 Edwards Lifesciences, LLC II Nov-06-2023
7 Edwards Lifesciences, LLC II Oct-28-2022
8 Edwards Lifesciences, LLC II Aug-26-2017
9 INARI MEDICAL II Jun-09-2020
10 LeMaitre Vascular, Inc. II May-15-2024
11 LeMaitre Vascular, Inc. II Nov-11-2022
12 LeMaitre Vascular, Inc. I Apr-01-2020
13 LeMaitre Vascular, Inc. II Dec-04-2015
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