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 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 400 400

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 645 645
Physical Resistance/Sticking 624 624
Break 592 592
Leak/Splash 190 190
Material Deformation 171 171
Detachment of Device or Device Component 140 140
Material Separation 119 119
Burst Container or Vessel 105 105
Fracture 87 87
Material Integrity Problem 85 85
Device Dislodged or Dislocated 76 76
Difficult to Remove 73 73
Difficult to Advance 73 73
Entrapment of Device 65 65
Device Damaged by Another Device 63 63
Material Twisted/Bent 47 47
Obstruction of Flow 40 40
Fluid/Blood Leak 35 35
Packaging Problem 32 32
Stretched 30 30
Material Perforation 29 29
No Apparent Adverse Event 28 28
Defective Device 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
Material Puncture/Hole 18 18
Failure to Advance 18 18
Deformation Due to Compressive Stress 17 17
Material Rupture 16 16
Unintended Movement 16 16
Difficult to Flush 15 15
Collapse 15 15
Contamination /Decontamination Problem 14 14
Device Fell 14 14
Output Problem 14 14
Compatibility Problem 13 13
Crack 13 13
Display or Visual Feedback Problem 13 13
Suction Problem 12 12
Device Displays Incorrect Message 11 11
Peeled/Delaminated 10 10
Temperature Problem 9 9
Material Split, Cut or Torn 9 9
Positioning Problem 7 7
Contamination 7 7
Unsealed Device Packaging 7 7
Connection Problem 6 6
Device Difficult to Setup or Prepare 6 6
Difficult to Insert 6 6
Device Contaminated During Manufacture or Shipping 6 6
Separation Problem 6 6
Appropriate Term/Code Not Available 6 6
Material Too Soft/Flexible 5 5
Material Frayed 5 5
Activation, Positioning or Separation Problem 5 5
Device Markings/Labelling Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Migration or Expulsion of Device 4 4
Tear, Rip or Hole in Device Packaging 4 4
Mechanical Jam 4 4
Disconnection 3 3
Backflow 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
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
Unexpected Shutdown 1 1
Poor Visibility 1 1
Device Handling Problem 1 1
Insufficient Information 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
Inflation 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
Communication or Transmission Problem 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1466 1466
No Consequences Or Impact To Patient 370 370
Intracranial Hemorrhage 192 192
No Known Impact Or Consequence To Patient 191 191
Foreign Body In Patient 128 128
Insufficient Information 118 118
Hemorrhage/Bleeding 103 103
Stroke/CVA 68 68
Device Embedded In Tissue or Plaque 65 65
Unspecified Nervous System Problem 60 60
Vasoconstriction 59 59
Obstruction/Occlusion 52 52
No Patient Involvement 49 49
Thrombosis/Thrombus 49 49
Ischemia Stroke 48 48
Thromboembolism 47 47
Hematoma 47 47
Vascular Dissection 42 42
Ischemia 39 39
Rupture 37 37
Embolism/Embolus 37 37
No Code Available 36 36
Swelling/ Edema 34 34
Stenosis 30 30
Paresis 29 29
Perforation of Vessels 24 24
Pain 22 22
Muscle Weakness 21 21
Pseudoaneurysm 21 21
Headache 20 20
Death 19 19
Dysphasia 18 18
Unspecified Infection 16 16
Paralysis 15 15
Hydrocephalus 15 15
Convulsion/Seizure 15 15
Perforation 14 14
Fistula 14 14
Transient Ischemic Attack 13 13
Visual Disturbances 13 13
Coma 12 12
Failure of Implant 12 12
Low Blood Pressure/ Hypotension 11 11
Cardiac Arrest 10 10
Arrhythmia 10 10
Confusion/ Disorientation 10 10
Nervous System Injury 10 10
Cognitive Changes 9 9
Renal Failure 9 9
Aneurysm 9 9
Pulmonary Embolism 8 8
Nerve Damage 8 8
Visual Impairment 8 8
Blood Loss 8 8
Unintended Radiation Exposure 8 8
Hemorrhagic Stroke 8 8
Respiratory Insufficiency 8 8
Ruptured Aneurysm 7 7
Heart Failure/Congestive Heart Failure 7 7
Respiratory Failure 7 7
Loss of Vision 7 7
Blurred Vision 7 7
Nausea 7 7
Bradycardia 7 7
Dyspnea 7 7
Thrombus 6 6
Skin Discoloration 5 5
Dizziness 5 5
Post Operative Wound Infection 5 5
Cerebral Edema 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
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
Extravasation 3 3
Foreign Body Reaction 3 3
Granuloma 3 3
Hemorrhage, Cerebral 3 3
Myocardial Infarction 3 3
Neuropathy 3 3
Retroperitoneal Hemorrhage 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Restenosis 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 Merit Medical Systems, Inc. II Jan-02-2024
5 Micro Therapeutics, Inc. II Aug-18-2022
-
-