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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, thrombus retriever
Definition The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Product CodeNRY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
  1.  K223545  APRO 70 Catheter and Alembic Aspiration Tubing
  2.  K230695  APRO 70 Catheter and Alembic Aspiration Tubing
  3.  K232971  APRO 55 Catheter and Alembic Aspiration Tubing
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 4
INNEUROCO INC.
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 6
MICRO THERAPEUTICS, INC., D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURAVI LTD.
  SUBSTANTIALLY EQUIVALENT 3
NEURAVI, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 16
PERFUZE LTD.
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAPID MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIA VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 497 497
2017 432 432
2018 415 415
2019 650 650
2020 703 703
2021 688 688
2022 549 549
2023 709 709
2024 183 183

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1895 1895
Break 911 911
Physical Resistance/Sticking 551 551
Material Deformation 396 396
Fracture 357 357
Device Damaged Prior to Use 270 270
Stretched 254 254
Failure to Advance 193 193
Out-Of-Box Failure 181 181
Kinked 179 179
Difficult to Remove 177 177
Physical Resistance 131 131
Retraction Problem 93 93
Material Separation 88 88
Suction Problem 88 88
Material Twisted/Bent 68 68
Unraveled Material 61 61
Difficult to Advance 58 58
Crack 41 41
Detachment of Device or Device Component 39 39
Device Handling Problem 38 38
Suction Failure 36 36
No Apparent Adverse Event 30 30
Aspiration Issue 26 26
Device Operates Differently Than Expected 26 26
Entrapment of Device 24 24
Material Puncture/Hole 24 24
Fluid/Blood Leak 23 23
Collapse 20 20
Leak/Splash 20 20
Mechanical Problem 20 20
Misconnection 20 20
Patient-Device Incompatibility 18 18
Deformation Due to Compressive Stress 18 18
Separation Failure 17 17
Detachment Of Device Component 13 13
Material Integrity Problem 12 12
Mechanical Jam 11 11
Power Problem 11 11
Pressure Problem 11 11
Appropriate Term/Code Not Available 11 11
Premature Separation 11 11
Material Split, Cut or Torn 11 11
Device Contamination with Body Fluid 11 11
Peeled/Delaminated 11 11
Failure to Power Up 9 9
Bent 9 9
Decrease in Suction 9 9
Noise, Audible 9 9
Activation Failure 8 8
Unclear Information 8 8
Packaging Problem 8 8
Material Frayed 8 8
Pumping Stopped 8 8
Component Missing 7 7
Material Fragmentation 7 7
Insufficient Information 7 7
Device Fell 7 7
Connection Problem 6 6
Device Emits Odor 6 6
Defective Device 5 5
Obstruction of Flow 5 5
Use of Device Problem 5 5
Occlusion Within Device 4 4
Flaked 4 4
Activation, Positioning or Separation Problem 4 4
Improper Flow or Infusion 4 4
No Pressure 3 3
Pumping Problem 3 3
Component or Accessory Incompatibility 3 3
Device Operational Issue 3 3
Migration 3 3
Positioning Problem 3 3
Lack of Effect 3 3
Activation Problem 3 3
Overheating of Device 3 3
Hole In Material 3 3
Loose or Intermittent Connection 2 2
Unsealed Device Packaging 2 2
Difficult to Insert 2 2
Positioning Failure 2 2
Display or Visual Feedback Problem 2 2
Backflow 2 2
Air Leak 2 2
Contamination 2 2
Product Quality Problem 2 2
Shipping Damage or Problem 2 2
Defective Component 2 2
Split 2 2
Separation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Device Damaged by Another Device 2 2
Device Dislodged or Dislocated 2 2
Contamination /Decontamination Problem 2 2
Infusion or Flow Problem 2 2
Device-Device Incompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Material Protrusion/Extrusion 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1210 1210
No Clinical Signs, Symptoms or Conditions 1005 1005
Intracranial Hemorrhage 680 680
No Patient Involvement 336 336
Thromboembolism 199 199
Death 183 183
Vasoconstriction 180 180
Vascular Dissection 174 174
Perforation of Vessels 165 165
Hemorrhage/Bleeding 159 159
Foreign Body In Patient 155 155
Stroke/CVA 145 145
No Known Impact Or Consequence To Patient 134 134
Hemorrhage, Subarachnoid 123 123
Device Embedded In Tissue or Plaque 108 108
Insufficient Information 93 93
Ischemia Stroke 92 92
Obstruction/Occlusion 85 85
Embolism/Embolus 85 85
Unspecified Nervous System Problem 82 82
Hemorrhage, Cerebral 82 82
Hematoma 81 81
Neurological Deficit/Dysfunction 72 72
Infarction, Cerebral 71 71
Swelling/ Edema 61 61
Embolus 56 56
Thrombosis/Thrombus 47 47
Stenosis 37 37
Perforation 35 35
Extravasation 32 32
Therapeutic Response, Decreased 30 30
Rupture 28 28
Edema 27 27
Ischemia 27 27
Pseudoaneurysm 26 26
Hemorrhagic Stroke 23 23
Fistula 23 23
Cerebral Edema 22 22
Occlusion 21 21
Paralysis 19 19
No Code Available 18 18
Muscle Weakness 15 15
Respiratory Failure 14 14
Cognitive Changes 13 13
Headache 13 13
Intimal Dissection 13 13
Paresis 12 12
Thrombosis 12 12
Dysphasia 12 12
Embolism 11 11
Coma 10 10
Heart Failure/Congestive Heart Failure 10 10
Patient Problem/Medical Problem 9 9
Hydrocephalus 9 9
Convulsion/Seizure 9 9
Thrombus 8 8
Low Blood Pressure/ Hypotension 8 8
Unspecified Infection 8 8
Hemorrhage, Intraventricular 7 7
High Blood Pressure/ Hypertension 7 7
Necrosis 7 7
Fever 7 7
Aspiration/Inhalation 7 7
Visual Impairment 7 7
Sepsis 6 6
Atrial Fibrillation 6 6
Anemia 6 6
Bradycardia 6 6
Failure of Implant 6 6
Pain 6 6
Inflammation 6 6
Vessel Or Plaque, Device Embedded In 5 5
Foreign Body Reaction 5 5
Visual Disturbances 5 5
Ventilator Dependent 5 5
Speech Disorder 5 5
No Information 5 5
Injury 4 4
Weakness 4 4
Brain Injury 4 4
Transient Ischemic Attack 4 4
Death, Intrauterine Fetal 4 4
Pulmonary Embolism 4 4
Seizures 4 4
Pneumonia 4 4
Restenosis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Respiratory Insufficiency 3 3
Renal Failure 3 3
Reocclusion 3 3
Hypersensitivity/Allergic reaction 3 3
Aneurysm 3 3
Arrhythmia 3 3
Cardiac Arrest 3 3
Fatigue 3 3
Hernia 3 3
Numbness 3 3
Loss of consciousness 3 3
Nervous System Injury 3 3
Blood Loss 3 3

Recalls
Manufacturer Recall Class Date Posted
1 IMPERATIVE CARE INC I Sep-29-2021
2 Micro Therapeutics Inc, Dba Ev3 Neurovascular I May-16-2018
3 Penumbra Inc. I Jan-18-2021
4 Penumbra Inc. I Jun-22-2017
5 ROUTE 92 MEDICAL INC I Apr-24-2024
6 Stryker Neurovascular II Mar-31-2020
7 Stryker Neurovascular II Jan-14-2018
8 Stryker Neurovascular II Dec-05-2017
9 Stryker Neurovascular II Jul-29-2017
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