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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 188 188

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8825 8825
Difficult to Remove 6943 6951
Appropriate Term/Code Not Available 6059 6059
Structural Problem 5014 5014
Unintended Movement 3846 3845
Malposition of Device 3840 3892
Adverse Event Without Identified Device or Use Problem 2920 2920
Detachment of Device or Device Component 2620 2630
Migration or Expulsion of Device 2589 2592
Device Tipped Over 2580 2580
Fracture 2498 2498
Patient Device Interaction Problem 2418 2471
Patient-Device Incompatibility 1600 1701
Failure to Align 1589 1589
Obstruction of Flow 1516 1516
Migration 1137 1139
Positioning Problem 692 694
Extrusion 612 612
Activation Failure 488 488
Entrapment of Device 453 453
Failure to Advance 424 424
Material Deformation 416 418
Inadequate Filtration Process 361 361
Activation, Positioning or Separation Problem 318 318
Break 215 215
Material Perforation 186 186
Occlusion Within Device 183 183
Detachment Of Device Component 156 156
Therapeutic or Diagnostic Output Failure 132 132
Positioning Failure 126 126
Difficult or Delayed Positioning 112 112
Difficult or Delayed Activation 110 110
Material Separation 108 108
Difficult to Advance 104 104
Premature Activation 103 103
Improper or Incorrect Procedure or Method 102 102
Material Twisted/Bent 99 99
Material Puncture/Hole 98 98
Device Dislodged or Dislocated 85 85
Kinked 83 83
Device Operates Differently Than Expected 82 82
Bent 62 62
Defective Device 60 60
Difficult to Insert 57 57
Complete Blockage 56 56
Material Fragmentation 56 56
Activation Problem 50 50
Retraction Problem 48 48
Deformation Due to Compressive Stress 44 44
Difficult to Open or Close 43 43
Physical Resistance/Sticking 37 37
Defective Component 34 34
Sticking 28 28
Therapy Delivered to Incorrect Body Area 28 28
Material Frayed 28 28
Failure to Unfold or Unwrap 25 25
Device Handling Problem 24 24
Material Protrusion/Extrusion 23 23
Off-Label Use 23 23
Output Problem 22 22
Material Split, Cut or Torn 20 20
Device Or Device Fragments Location Unknown 19 19
Material Erosion 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 12 12
Device Contamination with Chemical or Other Material 12 12
Component Missing 11 11
Difficult or Delayed Separation 11 11
Split 10 10
Physical Resistance 10 10
Device Markings/Labelling Problem 10 10
Device Misassembled During Manufacturing /Shipping 10 10
Device Difficult to Setup or Prepare 10 10
Loose or Intermittent Connection 9 9
Connection Problem 9 9
Filtration Problem 9 9
Other (for use when an appropriate device code cannot be identified) 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
Loss of or Failure to Bond 6 6
Component Incompatible 6 6
Peeled/Delaminated 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 10755 10755
No Information 8743 8743
Internal Organ Perforation 5358 5358
Pain 4144 4144
No Consequences Or Impact To Patient 3369 3376
Perforation 3028 3028
Anxiety 2791 2791
Vessel Or Plaque, Device Embedded In 2550 2550
Pulmonary Embolism 2457 2459
Thrombosis 2391 2391
No Clinical Signs, Symptoms or Conditions 2059 2231
No Known Impact Or Consequence To Patient 1837 1837
Abdominal Pain 1818 1818
Insufficient Information 1742 1742
Occlusion 1406 1406
Device Embedded In Tissue or Plaque 1307 1307
Injury 1084 1084
Thrombosis/Thrombus 1061 1061
No Code Available 1053 1053
Chest Pain 1033 1033
Dyspnea 874 874
Stenosis 865 865
Thrombus 844 844
Depression 840 840
Coagulation Disorder 734 734
Great Vessel Perforation 723 723
Death 616 617
Swelling 454 454
Foreign Body In Patient 431 431
Obstruction/Occlusion 367 367
Hemorrhage/Bleeding 325 325
Embolus 258 258
Numbness 190 190
Blood Loss 181 181
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 181 181
Discomfort 180 180
Failure of Implant 152 152
Cardiac Perforation 150 150
Emotional Changes 139 139
Hematoma 138 138
Swelling/ Edema 134 134
Distress 124 124
Ambulation Difficulties 111 111
Embolism 110 110
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 62 62
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 42 42
Cognitive Changes 39 39
Erosion 38 38
Scar Tissue 38 38
Low Blood Pressure/ Hypotension 37 37
Weakness 37 37
Embolism/Embolus 35 35
Tachycardia 34 34
Myocardial Infarction 33 33
Peripheral Edema 33 33
Cardiac Tamponade 32 32
No Patient Involvement 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
Foreign Body Embolism 25 25
Cramp(s) /Muscle Spasm(s) 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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