Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, continuous flush
Product CodeKRA
Regulation Number 870.1210
Device Class 2


Premarket Reviews
ManufacturerDecision
ABLATIVE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGILE DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
BEND IT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CALLISYN BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MERCATOR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRO THERAPEUATICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
SMARTWISE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRISALUS LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 2
VASCUPATENT MEDICAL (SHENZHEN) CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
VVT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 537 537
2018 434 434
2019 418 418
2020 381 381
2021 440 440
2022 543 543
2023 828 828
2024 266 266

Device Problems MDRs with this Device Problem Events in those MDRs
Break 801 801
Adverse Event Without Identified Device or Use Problem 715 715
Physical Resistance/Sticking 614 614
Leak/Splash 204 204
Material Separation 179 179
Material Deformation 176 176
Detachment of Device or Device Component 164 164
Fracture 134 134
Difficult to Remove 124 124
Burst Container or Vessel 118 118
Device Dislodged or Dislocated 105 105
Material Integrity Problem 93 93
Device Damaged by Another Device 82 82
Entrapment of Device 82 82
Difficult to Advance 79 79
Physical Resistance 74 74
Material Twisted/Bent 52 52
Device Displays Incorrect Message 50 50
Obstruction of Flow 48 48
Material Perforation 45 45
Detachment Of Device Component 44 44
Fluid/Blood Leak 43 43
Stretched 40 40
Aspiration Issue 35 35
Packaging Problem 32 32
No Apparent Adverse Event 29 29
Fitting Problem 29 29
Failure to Advance 29 29
Material Puncture/Hole 29 29
Kinked 28 28
Defective Device 28 28
Difficult to Open or Remove Packaging Material 27 27
Device Alarm System 26 26
Material Rupture 24 24
Deformation Due to Compressive Stress 19 19
Audible Prompt/Feedback Problem 18 18
Electrical /Electronic Property Problem 18 18
Difficult to Flush 16 16
Peeled/Delaminated 15 15
Display or Visual Feedback Problem 14 14
Collapse 14 14
Crack 14 14
Device Fell 14 14
Contamination /Decontamination Problem 14 14
Device Contamination with Chemical or Other Material 14 14
Suction Problem 13 13
Output Problem 13 13
Positioning Problem 12 12
Compatibility Problem 12 12
Device Inoperable 12 12
Difficult to Insert 11 11
Device Handling Problem 11 11
Material Split, Cut or Torn 10 10
Unintended Movement 10 10
Device Operates Differently Than Expected 10 10
Device Damaged Prior to Use 10 10
Occlusion Within Device 9 9
Temperature Problem 9 9
Device Difficult to Setup or Prepare 8 8
Sticking 7 7
Material Frayed 7 7
Contamination 7 7
Appropriate Term/Code Not Available 7 7
Separation Problem 7 7
Device Contaminated During Manufacture or Shipping 6 6
Electrical Shorting 6 6
Tear, Rip or Hole in Device Packaging 6 6
Connection Problem 6 6
Hole In Material 6 6
Unsealed Device Packaging 6 6
Activation, Positioning or Separation Problem 5 5
Device Markings/Labelling Problem 5 5
Insufficient Information 5 5
Material Too Soft/Flexible 4 4
Split 4 4
Migration or Expulsion of Device 4 4
Failure to Prime 4 4
Component Missing 4 4
Use of Device Problem 4 4
Material Fragmentation 4 4
Disconnection 4 4
Bent 4 4
Partial Blockage 3 3
Incorrect Measurement 3 3
Unraveled Material 3 3
Melted 3 3
Separation Failure 3 3
Difficult or Delayed Activation 3 3
Cut In Material 3 3
Device Packaging Compromised 3 3
Device-Device Incompatibility 3 3
Infusion or Flow Problem 3 3
Torn Material 3 3
Mechanical Jam 3 3
Radiation Underexposure 3 3
Therapeutic or Diagnostic Output Failure 2 2
Material Protrusion/Extrusion 2 2
Priming Problem 2 2
Sharp Edges 2 2
Human-Device Interface Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1364 1364
No Consequences Or Impact To Patient 696 696
No Known Impact Or Consequence To Patient 488 488
Intracranial Hemorrhage 198 198
Foreign Body In Patient 185 185
No Patient Involvement 116 116
Insufficient Information 115 115
Hemorrhage/Bleeding 107 107
Device Embedded In Tissue or Plaque 90 90
Stroke/CVA 68 68
No Code Available 68 68
Vasoconstriction 61 61
Unspecified Nervous System Problem 61 61
Hematoma 50 50
Thromboembolism 48 48
Obstruction/Occlusion 48 48
Thrombosis/Thrombus 48 48
Ischemia 40 40
Vascular Dissection 39 39
Ischemia Stroke 39 39
Rupture 38 38
Death 37 37
Embolism/Embolus 35 35
Paresis 34 34
Perforation of Vessels 34 34
Perforation 33 33
Swelling/ Edema 33 33
Stenosis 32 32
Vascular System (Circulation), Impaired 26 26
Pain 26 26
Headache 22 22
Pseudoaneurysm 19 19
Dysphasia 19 19
Muscle Weakness 19 19
Thrombosis 17 17
Fistula 17 17
Unspecified Infection 16 16
Paralysis 15 15
Thrombus 15 15
Convulsion/Seizure 15 15
Hydrocephalus 15 15
Low Blood Pressure/ Hypotension 14 14
Transient Ischemic Attack 13 13
Visual Disturbances 13 13
Cardiac Arrest 12 12
Blood Loss 12 12
Failure of Implant 12 12
Coma 11 11
Bradycardia 11 11
Pulmonary Embolism 11 11
Aneurysm 11 11
Neurological Deficit/Dysfunction 11 11
Renal Failure 11 11
Arrhythmia 10 10
Confusion/ Disorientation 10 10
No Information 9 9
Cognitive Changes 9 9
Nerve Damage 9 9
Hemorrhage, Subarachnoid 8 8
Infarction, Cerebral 8 8
Respiratory Insufficiency 8 8
Dyspnea 8 8
Visual Impairment 8 8
Nausea 8 8
Hemorrhagic Stroke 8 8
Ruptured Aneurysm 7 7
Heart Failure/Congestive Heart Failure 7 7
Unintended Radiation Exposure 7 7
Respiratory Failure 7 7
Blurred Vision 7 7
Loss of Vision 7 7
Hypersensitivity/Allergic reaction 6 6
Chest Pain 6 6
Dizziness 6 6
Foreign Body Reaction 6 6
Hemoptysis 5 5
Abdominal Pain 5 5
Sepsis 5 5
Fatigue 5 5
Skin Discoloration 5 5
Post Operative Wound Infection 5 5
Radiation Exposure, Unintended 5 5
Embolism 5 5
Fever 5 5
High Blood Pressure/ Hypertension 5 5
Speech Disorder 5 5
Occlusion 4 4
Syncope/Fainting 4 4
Encephalopathy 4 4
Atrial Fibrillation 4 4
Vomiting 4 4
Cerebral Edema 4 4
Nervous System Injury 4 4
Aspiration/Inhalation 4 4
Inflammation 3 3
Hemorrhage, Cerebral 3 3
Anemia 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Paraplegia 3 3
Granuloma 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Feb-07-2024
2 Boston Scientific Corporation II Dec-17-2020
3 Cook Inc. I Dec-09-2019
4 Cook Inc. II Mar-02-2017
5 Merit Medical Systems, Inc. II Jan-02-2024
6 Micro Therapeutics, Inc. II Aug-18-2022
7 Vascular Insights, LLC II Mar-21-2018
-
-