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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
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 4
INNEUROCO, INC
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURAVI LTD.
  SUBSTANTIALLY EQUIVALENT 2
NEURAVI, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 8
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 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 650 650
2020 703 703
2021 688 688
2022 549 549
2023 709 709
2024 293 293

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1500 1500
Break 650 650
Physical Resistance/Sticking 535 535
Material Deformation 344 344
Fracture 280 280
Stretched 202 202
Failure to Advance 145 145
Difficult to Remove 137 137
Suction Problem 79 79
Material Twisted/Bent 70 70
Material Separation 65 65
Retraction Problem 63 63
Difficult to Advance 48 48
Unraveled Material 43 43
Suction Failure 35 35
Crack 33 33
No Apparent Adverse Event 30 30
Device Damaged Prior to Use 29 29
Detachment of Device or Device Component 28 28
Material Puncture/Hole 22 22
Fluid/Blood Leak 21 21
Leak/Splash 18 18
Separation Failure 16 16
Patient-Device Incompatibility 13 13
Pressure Problem 11 11
Premature Separation 11 11
Material Split, Cut or Torn 10 10
Misconnection 10 10
Peeled/Delaminated 9 9
Entrapment of Device 9 9
Packaging Problem 9 9
Appropriate Term/Code Not Available 9 9
Unclear Information 8 8
Power Problem 8 8
Device Contamination with Body Fluid 7 7
Collapse 7 7
Device Fell 7 7
Activation Failure 7 7
Device Handling Problem 6 6
Insufficient Information 6 6
Mechanical Problem 6 6
Material Frayed 6 6
Failure to Power Up 6 6
Deformation Due to Compressive Stress 6 6
Connection Problem 5 5
Use of Device Problem 5 5
Noise, Audible 5 5
Component Missing 4 4
Activation, Positioning or Separation Problem 4 4
Positioning Problem 3 3
Component or Accessory Incompatibility 3 3
Device Emits Odor 3 3
Material Fragmentation 3 3
Decrease in Suction 3 3
Migration 3 3
Unintended Movement 3 3
Lack of Effect 3 3
Activation Problem 3 3
Separation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Pumping Problem 2 2
Contamination 2 2
Pumping Stopped 2 2
Display or Visual Feedback Problem 2 2
Unsealed Device Packaging 2 2
Product Quality Problem 2 2
Infusion or Flow Problem 2 2
Material Integrity Problem 2 2
Device Dislodged or Dislocated 2 2
Contamination /Decontamination Problem 2 2
Defective Device 1 1
Malposition of Device 1 1
Dent in Material 1 1
Incomplete or Missing Packaging 1 1
Vibration 1 1
Obstruction of Flow 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Material Protrusion/Extrusion 1 1
Failure to Unfold or Unwrap 1 1
Inadequacy of Device Shape and/or Size 1 1
Overheating of Device 1 1
Delivered as Unsterile Product 1 1
Burst Container or Vessel 1 1
Positioning Failure 1 1
Flaked 1 1
Difficult to Flush 1 1
Image Display Error/Artifact 1 1
Scratched Material 1 1
Material Too Soft/Flexible 1 1
Patient Device Interaction Problem 1 1
Complete Loss of Power 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1051 1051
No Consequences Or Impact To Patient 764 764
Intracranial Hemorrhage 602 602
Thromboembolism 156 156
Hemorrhage/Bleeding 151 151
Vascular Dissection 150 150
Vasoconstriction 148 148
Stroke/CVA 135 135
Perforation of Vessels 129 129
Foreign Body In Patient 114 114
Ischemia Stroke 106 106
Insufficient Information 95 95
Embolism/Embolus 91 91
Obstruction/Occlusion 89 89
Unspecified Nervous System Problem 85 85
Death 81 81
Hematoma 74 74
Device Embedded In Tissue or Plaque 73 73
No Known Impact Or Consequence To Patient 64 64
No Patient Involvement 62 62
Swelling/ Edema 62 62
Thrombosis/Thrombus 48 48
Hemorrhage, Subarachnoid 41 41
Infarction, Cerebral 38 38
Stenosis 32 32
Rupture 28 28
Cerebral Edema 28 28
Hemorrhage, Cerebral 28 28
Perforation 24 24
Hemorrhagic Stroke 24 24
Pseudoaneurysm 23 23
Ischemia 22 22
Fistula 22 22
Extravasation 19 19
Embolus 18 18
Muscle Weakness 17 17
Paralysis 16 16
No Code Available 15 15
Cognitive Changes 15 15
Occlusion 14 14
Respiratory Failure 13 13
Dysphasia 13 13
Paresis 12 12
Headache 12 12
Therapeutic Response, Decreased 11 11
Coma 10 10
Hydrocephalus 10 10
Heart Failure/Congestive Heart Failure 10 10
Edema 10 10
Convulsion/Seizure 9 9
Nervous System Injury 8 8
Aspiration/Inhalation 7 7
Neurological Deficit/Dysfunction 7 7
Unspecified Infection 7 7
High Blood Pressure/ Hypertension 7 7
Low Blood Pressure/ Hypotension 7 7
Failure of Implant 6 6
Inflammation 6 6
Sepsis 6 6
Fever 6 6
Thrombosis 6 6
Pain 6 6
Visual Impairment 5 5
Visual Disturbances 5 5
Ventilator Dependent 5 5
Speech Disorder 5 5
Bradycardia 5 5
Embolism 5 5
Aneurysm 5 5
Atrial Fibrillation 4 4
Pneumonia 4 4
Necrosis 4 4
Restenosis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Injury 4 4
Transient Ischemic Attack 4 4
Brain Injury 4 4
Weakness 3 3
Loss of consciousness 3 3
Respiratory Insufficiency 3 3
Hypersensitivity/Allergic reaction 3 3
Renal Failure 3 3
Bacterial Infection 3 3
Arrhythmia 3 3
Pulmonary Embolism 3 3
Fatigue 3 3
Anemia 2 2
Foreign Body Reaction 2 2
Intimal Dissection 2 2
Burn(s) 2 2
Cardiac Arrest 2 2
Shock 2 2
Tachycardia 2 2
Ruptured Aneurysm 2 2
Foreign Body Embolism 2 2
Renal Impairment 2 2
Cancer 2 2
No Information 2 2
Numbness 2 2
Paraplegia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 IMPERATIVE CARE INC I Sep-29-2021
2 Penumbra Inc. I Jan-18-2021
3 ROUTE 92 MEDICAL INC I Apr-24-2024
4 Stryker Neurovascular II May-28-2024
5 Stryker Neurovascular II Mar-31-2020
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