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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
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 2
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 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
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
Adverse Event Without Identified Device or Use Problem 620 620
Physical Resistance/Sticking 586 586
Break 575 575
Leak/Splash 168 168
Material Deformation 153 153
Detachment of Device or Device Component 136 136
Material Separation 119 119
Burst Container or Vessel 96 96
Fracture 85 85
Material Integrity Problem 82 82
Device Dislodged or Dislocated 74 74
Difficult to Remove 71 71
Difficult to Advance 68 68
Entrapment of Device 63 63
Device Damaged by Another Device 62 62
Material Twisted/Bent 46 46
Obstruction of Flow 40 40
Fluid/Blood Leak 34 34
Packaging Problem 31 31
Stretched 29 29
Material Perforation 28 28
Defective Device 27 27
No Apparent Adverse Event 27 27
Device Alarm System 25 25
Difficult to Open or Remove Packaging Material 24 24
Audible Prompt/Feedback Problem 18 18
Electrical /Electronic Property Problem 18 18
Failure to Advance 18 18
Material Puncture/Hole 17 17
Deformation Due to Compressive Stress 17 17
Difficult to Flush 15 15
Collapse 14 14
Material Rupture 14 14
Device Fell 14 14
Contamination /Decontamination Problem 13 13
Display or Visual Feedback Problem 13 13
Crack 12 12
Suction Problem 12 12
Compatibility Problem 12 12
Output Problem 11 11
Device Displays Incorrect Message 11 11
Unintended Movement 10 10
Material Split, Cut or Torn 9 9
Temperature Problem 9 9
Peeled/Delaminated 9 9
Contamination 7 7
Positioning Problem 7 7
Device Contaminated During Manufacture or Shipping 6 6
Separation Problem 6 6
Device Difficult to Setup or Prepare 6 6
Difficult to Insert 6 6
Unsealed Device Packaging 6 6
Connection Problem 5 5
Activation, Positioning or Separation Problem 5 5
Device Markings/Labelling Problem 5 5
Material Frayed 5 5
Appropriate Term/Code Not Available 5 5
Material Too Soft/Flexible 4 4
Tear, Rip or Hole in Device Packaging 4 4
Migration or Expulsion of Device 4 4
Device Contamination with Chemical or Other Material 4 4
Use of Device Problem 3 3
Separation Failure 3 3
Difficult or Delayed Activation 3 3
Disconnection 3 3
Mechanical Jam 3 3
Infusion or Flow Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Sharp Edges 2 2
Priming Problem 2 2
Backflow 2 2
Loss of or Failure to Bond 2 2
Unable to Obtain Readings 2 2
Human-Device Interface Problem 2 2
Device-Device Incompatibility 2 2
Inappropriate or Unexpected Reset 1 1
Patient-Device Incompatibility 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Retraction Problem 1 1
Defective Alarm 1 1
Signal Artifact/Noise 1 1
Complete Blockage 1 1
Thermal Decomposition of Device 1 1
Deflation Problem 1 1
Flushing Problem 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Failure to Prime 1 1
Off-Label Use 1 1
Failure to Power Up 1 1
Activation Problem 1 1
Poor Visibility 1 1
Unexpected Shutdown 1 1

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 370 370
No Known Impact Or Consequence To Patient 191 191
Intracranial Hemorrhage 183 183
Foreign Body In Patient 121 121
Insufficient Information 115 115
Hemorrhage/Bleeding 101 101
Stroke/CVA 67 67
Device Embedded In Tissue or Plaque 64 64
Unspecified Nervous System Problem 60 60
Vasoconstriction 57 57
No Patient Involvement 49 49
Thrombosis/Thrombus 48 48
Obstruction/Occlusion 48 48
Hematoma 47 47
Thromboembolism 46 46
Ischemia Stroke 39 39
Vascular Dissection 38 38
Ischemia 38 38
No Code Available 36 36
Rupture 36 36
Embolism/Embolus 35 35
Swelling/ Edema 33 33
Stenosis 30 30
Paresis 25 25
Perforation of Vessels 24 24
Pain 21 21
Headache 20 20
Death 19 19
Muscle Weakness 19 19
Pseudoaneurysm 19 19
Dysphasia 18 18
Hydrocephalus 15 15
Convulsion/Seizure 15 15
Paralysis 15 15
Unspecified Infection 15 15
Perforation 14 14
Fistula 14 14
Transient Ischemic Attack 13 13
Visual Disturbances 13 13
Failure of Implant 12 12
Low Blood Pressure/ Hypotension 11 11
Coma 11 11
Confusion/ Disorientation 10 10
Cardiac Arrest 10 10
Aneurysm 9 9
Arrhythmia 9 9
Cognitive Changes 9 9
Renal Failure 9 9
Blood Loss 8 8
Hemorrhagic Stroke 8 8
Pulmonary Embolism 8 8
Nerve Damage 8 8
Respiratory Insufficiency 8 8
Heart Failure/Congestive Heart Failure 7 7
Unintended Radiation Exposure 7 7
Nausea 7 7
Bradycardia 7 7
Dyspnea 7 7
Ruptured Aneurysm 7 7
Blurred Vision 7 7
Visual Impairment 7 7
Loss of Vision 7 7
Thrombus 6 6
Respiratory Failure 6 6
Post Operative Wound Infection 5 5
Dizziness 5 5
Skin Discoloration 5 5
Speech Disorder 5 5
Chest Pain 5 5
Fatigue 5 5
High Blood Pressure/ Hypertension 5 5
Hypersensitivity/Allergic reaction 4 4
Hemorrhage, Subarachnoid 4 4
Fever 4 4
Encephalopathy 4 4
Infarction, Cerebral 4 4
Abdominal Pain 4 4
Aspiration/Inhalation 4 4
Syncope/Fainting 4 4
Cerebral Edema 4 4
Nervous System Injury 4 4
Sepsis 4 4
Thrombosis 3 3
Vomiting 3 3
Paraplegia 3 3
Numbness 3 3
Atrial Fibrillation 3 3
Bacterial Infection 3 3
Abscess 3 3
Anemia 3 3
Foreign Body Reaction 3 3
Granuloma 3 3
Hemorrhage, Cerebral 3 3
Myocardial Infarction 3 3
Neuropathy 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Retroperitoneal Hemorrhage 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Restenosis 2 2

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 Merit Medical Systems, Inc. II Jan-02-2024
5 Micro Therapeutics, Inc. II Aug-18-2022
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