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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
ALN S.A.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
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 283 283

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8825 8825
Difficult to Remove 6964 6972
Appropriate Term/Code Not Available 6066 6066
Structural Problem 5033 5033
Unintended Movement 3859 3858
Malposition of Device 3841 3893
Adverse Event Without Identified Device or Use Problem 2921 2921
Detachment of Device or Device Component 2645 2655
Device Tipped Over 2595 2595
Migration or Expulsion of Device 2589 2592
Fracture 2500 2500
Patient Device Interaction Problem 2418 2471
Patient-Device Incompatibility 1602 1703
Failure to Align 1589 1589
Obstruction of Flow 1526 1526
Migration 1139 1141
Positioning Problem 695 697
Extrusion 612 612
Activation Failure 504 504
Entrapment of Device 455 455
Failure to Advance 428 428
Material Deformation 418 420
Inadequate Filtration Process 365 365
Activation, Positioning or Separation Problem 321 321
Break 216 216
Material Perforation 186 186
Occlusion Within Device 183 183
Detachment Of Device Component 156 156
Therapeutic or Diagnostic Output Failure 132 132
Positioning Failure 128 128
Difficult or Delayed Positioning 112 112
Difficult or Delayed Activation 111 111
Material Separation 108 108
Difficult to Advance 107 107
Premature Activation 104 104
Improper or Incorrect Procedure or Method 104 104
Material Puncture/Hole 99 99
Material Twisted/Bent 99 99
Device Dislodged or Dislocated 91 91
Kinked 83 83
Device Operates Differently Than Expected 82 82
Bent 62 62
Difficult to Insert 62 62
Defective Device 60 60
Complete Blockage 56 56
Material Fragmentation 56 56
Activation Problem 50 50
Retraction Problem 49 49
Deformation Due to Compressive Stress 47 47
Difficult to Open or Close 43 43

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 10773 10773
No Information 8743 8743
Internal Organ Perforation 5367 5367
Pain 4152 4152
No Consequences Or Impact To Patient 3369 3376
Perforation 3030 3030
Anxiety 2801 2801
Vessel Or Plaque, Device Embedded In 2550 2550
Pulmonary Embolism 2460 2462
Thrombosis 2391 2391
No Clinical Signs, Symptoms or Conditions 2109 2281
No Known Impact Or Consequence To Patient 1837 1837
Abdominal Pain 1824 1824
Insufficient Information 1755 1755
Occlusion 1406 1406
Device Embedded In Tissue or Plaque 1320 1320
Injury 1084 1084
Thrombosis/Thrombus 1070 1070
No Code Available 1053 1053
Chest Pain 1036 1036
Dyspnea 877 877
Stenosis 866 866
Depression 845 845
Thrombus 844 844
Coagulation Disorder 734 734
Great Vessel Perforation 723 723
Death 616 617
Swelling 454 454
Foreign Body In Patient 438 438
Obstruction/Occlusion 371 371
Hemorrhage/Bleeding 325 325
Embolus 258 258
Numbness 191 191
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 186 186
Discomfort 182 182
Blood Loss 181 181
Failure of Implant 153 153
Cardiac Perforation 150 150
Emotional Changes 139 139
Hematoma 138 138
Swelling/ Edema 134 134
Distress 125 125
Ambulation Difficulties 113 113
Embolism 110 110
Bowel Perforation 102 102
Edema 99 99
Vascular System (Circulation), Impaired 95 95
Fatigue 91 91
Unspecified Tissue Injury 86 85
Disability 86 86

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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