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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, intravascular, cardiovascular
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
ALN IMPLANTS CHIRURGICAUX
  SUBSTANTIALLY EQUIVALENT 2
B.BRAUN INTERVENTIONAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 6
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP., A JOHNSON & JOHNSON CO.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS, A JOHNSON & JOHNSON CO.
  SUBSTANTIALLY EQUIVALENT 1
CRUX BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NOVATE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
REX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL LP
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, LP
  SUBSTANTIALLY EQUIVALENT 1
RMT MEDICAL TECHNILOGIES INC.
  SE - WITH LIMITATIONS 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 10

MDR Year MDR Reports MDR Events
2014 451 451
2015 858 858
2016 2576 2576
2017 4364 4364
2018 3938 3938
2019 6467 6474
2020 5404 5404
2021 5357 5516
2022 2191 2196
2023 584 584
2024 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8824 8824
Difficult to Remove 6934 6942
Appropriate Term/Code Not Available 6059 6059
Structural Problem 4999 4999
Unintended Movement 3839 3838
Malposition of Device 3834 3886
Adverse Event Without Identified Device or Use Problem 2917 2917
Detachment of Device or Device Component 2595 2605
Migration or Expulsion of Device 2589 2592
Device Tipped Over 2568 2568
Fracture 2497 2497
Patient Device Interaction Problem 2418 2471
Patient-Device Incompatibility 1592 1693
Failure to Align 1588 1588
Obstruction of Flow 1509 1509
Migration 1134 1136
Positioning Problem 690 692
Extrusion 612 612
Activation Failure 480 480
Entrapment of Device 453 453
Material Deformation 415 417
Failure to Advance 408 408
Inadequate Filtration Process 356 356
Activation, Positioning or Separation Problem 318 318
Break 212 212
Material Perforation 186 186
Occlusion Within Device 183 183
Detachment Of Device Component 156 156
Therapeutic or Diagnostic Output Failure 132 132
Positioning Failure 124 124
Difficult or Delayed Positioning 112 112
Difficult or Delayed Activation 109 109
Material Separation 108 108
Difficult to Advance 103 103
Improper or Incorrect Procedure or Method 101 101
Premature Activation 101 101
Material Twisted/Bent 99 99
Material Puncture/Hole 95 95
Device Dislodged or Dislocated 84 84
Kinked 83 83
Device Operates Differently Than Expected 82 82
Bent 62 62
Defective Device 60 60
Complete Blockage 56 56
Material Fragmentation 56 56
Difficult to Insert 56 56
Activation Problem 50 50
Retraction Problem 48 48
Difficult to Open or Close 43 43
Deformation Due to Compressive Stress 41 41
Physical Resistance/Sticking 36 36
Defective Component 34 34
Sticking 28 28
Therapy Delivered to Incorrect Body Area 28 28
Material Frayed 25 25
Device Handling Problem 24 24
Material Protrusion/Extrusion 23 23
Off-Label Use 23 23
Output Problem 22 22
Failure to Unfold or Unwrap 21 21
Device Or Device Fragments Location Unknown 19 19
Material Erosion 18 18
Material Split, Cut or Torn 18 18
Torn Material 17 17
Partial Blockage 16 16
Use of Device Problem 14 14
Unexpected Therapeutic Results 13 13
Collapse 13 13
Crack 11 11
Component Missing 11 11
Device Contamination with Chemical or Other Material 11 11
Difficult or Delayed Separation 11 11
Physical Resistance 10 10
Device Markings/Labelling Problem 10 10
Device Misassembled During Manufacturing /Shipping 10 10
Split 10 10
Device Difficult to Setup or Prepare 10 10
Loose or Intermittent Connection 9 9
Other (for use when an appropriate device code cannot be identified) 9 9
Connection Problem 9 9
Filtration Problem 9 9
Device Issue 8 8
Mechanical Problem 8 8
Leak/Splash 8 8
Coagulation in Device or Device Ingredient 8 8
Sharp Edges 8 8
No Apparent Adverse Event 8 8
Mechanical Jam 8 8
Material Integrity Problem 7 7
Packaging Problem 7 7
Difficult to Fold, Unfold or Collapse 7 7
Difficult To Position 7 7
Device-Device Incompatibility 7 7
Device Damaged by Another Device 6 6
Material Distortion 6 6
Tear, Rip or Hole in Device Packaging 6 6
Failure to Capture 6 6
Component Incompatible 6 6
Loss of or Failure to Bond 5 5
Peeled/Delaminated 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 10739 10739
No Information 8743 8743
Internal Organ Perforation 5350 5350
Pain 4138 4138
No Consequences Or Impact To Patient 3369 3376
Perforation 3026 3026
Anxiety 2782 2782
Vessel Or Plaque, Device Embedded In 2550 2550
Pulmonary Embolism 2450 2452
Thrombosis 2391 2391
No Clinical Signs, Symptoms or Conditions 2010 2182
No Known Impact Or Consequence To Patient 1837 1837
Abdominal Pain 1814 1814
Insufficient Information 1738 1738
Occlusion 1406 1406
Device Embedded In Tissue or Plaque 1298 1298
Injury 1084 1084
No Code Available 1053 1053
Thrombosis/Thrombus 1051 1051
Chest Pain 1030 1030
Dyspnea 871 871
Stenosis 863 863
Thrombus 844 844
Depression 836 836
Coagulation Disorder 734 734
Great Vessel Perforation 723 723
Death 616 617
Swelling 454 454
Foreign Body In Patient 427 427
Obstruction/Occlusion 365 365
Hemorrhage/Bleeding 324 324
Embolus 258 258
Numbness 190 190
Blood Loss 181 181
Discomfort 180 180
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 178 178
Failure of Implant 151 151
Cardiac Perforation 150 150
Emotional Changes 139 139
Hematoma 138 138
Swelling/ Edema 134 134
Distress 124 124
Embolism 110 110
Ambulation Difficulties 108 108
Bowel Perforation 102 102
Edema 99 99
Vascular System (Circulation), Impaired 95 95
Fatigue 90 90
Disability 86 86
Unspecified Tissue Injury 86 85
Scarring 77 77
Pericardial Effusion 75 75
Nausea 70 70
Thromboembolism 60 60
Dizziness 57 57
Stroke/CVA 56 56
Sleep Dysfunction 53 53
Unspecified Infection 51 51
Headache 46 46
Unspecified Mental, Emotional or Behavioural Problem 46 46
Cardiac Arrest 41 41
Cognitive Changes 39 39
Erosion 38 38
Scar Tissue 38 38
Low Blood Pressure/ Hypotension 37 37
Weakness 37 37
Embolism/Embolus 35 35
Myocardial Infarction 33 33
Tachycardia 32 32
Cardiac Tamponade 32 32
No Patient Involvement 32 32
Peripheral Edema 32 32
Pseudoaneurysm 31 31
Abdominal Cramps 31 31
Inflammation 31 31
Extravasation 31 31
High Blood Pressure/ Hypertension 30 30
Sepsis 29 29
Hematuria 29 29
Loss of Vision 28 28
Renal Failure 28 28
Bone Fracture(s) 27 27
Cramp(s) 26 26
Cramp(s) /Muscle Spasm(s) 24 24
Foreign Body Embolism 24 24
Ulcer 23 23
Calcium Deposits/Calcification 23 23
Arrhythmia 23 23
Aneurysm 22 22
Vomiting 22 22
Complaint, Ill-Defined 21 21
Chest Tightness/Pressure 21 21
Patient Problem/Medical Problem 21 21
Atrial Fibrillation 21 21
Muscle Weakness 20 20
Nerve Damage 19 19
Weight Changes 19 19
Palpitations 19 19
Tissue Damage 18 18
Cellulitis 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Jul-27-2023
2 Bard Peripheral Vascular Inc II Mar-08-2016
3 Bard Peripheral Vascular Inc II Feb-01-2016
4 Cook Medical Incorporated III Apr-06-2022
5 Cook Medical Incorporated III Mar-19-2019
6 Cordis Corporation II Oct-25-2013
7 Cordis Corporation I Aug-07-2013
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