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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 189 189

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 598 598
Break 564 564
Physical Resistance/Sticking 559 559
Leak/Splash 164 164
Material Deformation 146 146
Detachment of Device or Device Component 134 134
Material Separation 119 119
Burst Container or Vessel 96 96
Fracture 85 85
Material Integrity Problem 81 81
Difficult to Remove 70 70
Device Dislodged or Dislocated 70 70
Difficult to Advance 68 68
Entrapment of Device 62 62
Device Damaged by Another Device 58 58
Material Twisted/Bent 43 43
Obstruction of Flow 40 40
Fluid/Blood Leak 34 34
Packaging Problem 31 31
Stretched 29 29
Material Perforation 27 27
Defective Device 26 26
Device Alarm System 25 25
No Apparent Adverse Event 25 25
Difficult to Open or Remove Packaging Material 23 23
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
Device Displays Incorrect Message 11 11
Unintended Movement 10 10
Temperature Problem 9 9
Output Problem 9 9
Peeled/Delaminated 9 9
Material Split, Cut or Torn 8 8
Contamination 7 7
Device Difficult to Setup or Prepare 6 6
Difficult to Insert 6 6
Unsealed Device Packaging 6 6
Separation Problem 6 6
Device Contaminated During Manufacture or Shipping 6 6
Positioning Problem 5 5
Appropriate Term/Code Not Available 5 5
Activation, Positioning or Separation Problem 5 5
Device Markings/Labelling Problem 5 5
Material Frayed 5 5
Migration or Expulsion of Device 4 4
Device Contamination with Chemical or Other Material 4 4
Tear, Rip or Hole in Device Packaging 4 4
Material Too Soft/Flexible 4 4
Mechanical Jam 3 3
Connection Problem 3 3
Use of Device Problem 3 3
Separation Failure 3 3
Difficult or Delayed Activation 3 3
Unable to Obtain Readings 2 2
Human-Device Interface Problem 2 2
Device-Device Incompatibility 2 2
Disconnection 2 2
Backflow 2 2
Loss of or Failure to Bond 2 2
Infusion or Flow Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Sharp Edges 2 2
Priming Problem 2 2
Activation Problem 1 1
Poor Visibility 1 1
Unexpected Shutdown 1 1
Device Handling Problem 1 1
Pressure 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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1318 1318
No Consequences Or Impact To Patient 370 370
No Known Impact Or Consequence To Patient 191 191
Intracranial Hemorrhage 179 179
Foreign Body In Patient 117 117
Insufficient Information 111 111
Hemorrhage/Bleeding 99 99
Stroke/CVA 67 67
Device Embedded In Tissue or Plaque 64 64
Unspecified Nervous System Problem 57 57
Vasoconstriction 53 53
No Patient Involvement 49 49
Obstruction/Occlusion 46 46
Thromboembolism 45 45
Hematoma 45 45
Thrombosis/Thrombus 44 44
Ischemia 37 37
No Code Available 36 36
Vascular Dissection 36 36
Rupture 35 35
Ischemia Stroke 34 34
Embolism/Embolus 32 32
Swelling/ Edema 32 32
Stenosis 29 29
Perforation of Vessels 24 24
Paresis 23 23
Pain 21 21
Muscle Weakness 19 19
Death 19 19
Headache 19 19
Dysphasia 17 17
Pseudoaneurysm 17 17
Hydrocephalus 15 15
Convulsion/Seizure 15 15
Paralysis 15 15
Unspecified Infection 15 15
Perforation 14 14
Fistula 14 14
Visual Disturbances 13 13
Transient Ischemic Attack 12 12
Failure of Implant 12 12
Coma 11 11
Low Blood Pressure/ Hypotension 10 10
Cardiac Arrest 10 10
Arrhythmia 9 9
Cognitive Changes 9 9
Confusion/ Disorientation 9 9
Renal Failure 9 9
Blood Loss 8 8
Aneurysm 8 8
Nerve Damage 8 8
Nausea 7 7
Bradycardia 7 7
Pulmonary Embolism 7 7
Dyspnea 7 7
Visual Impairment 7 7
Loss of Vision 7 7
Unintended Radiation Exposure 7 7
Heart Failure/Congestive Heart Failure 7 7
Respiratory Insufficiency 7 7
Thrombus 6 6
Blurred Vision 6 6
Respiratory Failure 6 6
Ruptured Aneurysm 6 6
Dizziness 5 5
Skin Discoloration 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
Abdominal Pain 4 4
Aspiration/Inhalation 4 4
Infarction, Cerebral 4 4
Sepsis 4 4
Post Operative Wound Infection 4 4
Hemorrhagic Stroke 4 4
Nervous System Injury 4 4
Speech Disorder 3 3
Syncope/Fainting 3 3
Paraplegia 3 3
Numbness 3 3
Thrombosis 3 3
Vomiting 3 3
Anemia 3 3
Atrial Fibrillation 3 3
Bacterial Infection 3 3
Abscess 3 3
Foreign Body Reaction 3 3
Hemorrhage, Cerebral 3 3
Myocardial Infarction 3 3
Neuropathy 3 3
Retroperitoneal Hemorrhage 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Restenosis 2 2
Unspecified Vascular Problem 2 2
Pneumonia 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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