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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
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 4
INNEUROCO INC.
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 9
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 22
PERFUZE LTD.
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAPID MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 3
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2014 428 428
2015 598 598
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 2276 2276
Break 1004 1004
Physical Resistance/Sticking 551 551
Fracture 478 478
Material Deformation 401 401
Device Damaged Prior to Use 292 292
Kinked 281 281
Stretched 272 272
Out-Of-Box Failure 233 233
Difficult to Remove 214 214
Failure to Advance 210 210
Physical Resistance 152 152
Insufficient Information 118 118
Material Separation 104 104
Retraction Problem 100 100
Suction Problem 92 92
Difficult to Advance 72 72
Device Operates Differently Than Expected 70 70
Material Twisted/Bent 69 69
Unraveled Material 66 66
Crack 52 52
Detachment of Device or Device Component 49 49
Device Handling Problem 40 40
Leak/Splash 38 38
Suction Failure 36 36
Aspiration Issue 34 34
Detachment Of Device Component 33 33
Fluid/Blood Leak 32 32
Entrapment of Device 31 31
No Apparent Adverse Event 30 30
Collapse 24 24
Material Puncture/Hole 24 24
Patient-Device Incompatibility 22 22
Occlusion Within Device 21 21
Mechanical Problem 20 20
Misconnection 20 20
Deformation Due to Compressive Stress 18 18
Separation Failure 17 17
Bent 14 14
Material Integrity Problem 13 13
Appropriate Term/Code Not Available 12 12
Device Contamination with Body Fluid 12 12
Improper or Incorrect Procedure or Method 12 12
Peeled/Delaminated 11 11
Mechanical Jam 11 11
Power Problem 11 11
Pressure Problem 11 11
Premature Separation 11 11
Material Split, Cut or Torn 11 11
Noise, Audible 10 10
Failure to Power Up 9 9
Decrease in Suction 9 9
Hole In Material 9 9
Material Fragmentation 8 8
Material Frayed 8 8
Component Missing 8 8
Pumping Stopped 8 8
Activation Failure 8 8
Packaging Problem 8 8
Unclear Information 8 8
Device Fell 7 7
Connection Problem 7 7
Device Operational Issue 7 7
Sticking 7 7
Use of Device Problem 6 6
Device Emits Odor 6 6
Difficult to Insert 6 6
Air Leak 6 6
Obstruction of Flow 6 6
Defective Device 6 6
Device Packaging Compromised 5 5
Human-Device Interface Problem 5 5
Positioning Problem 5 5
Migration or Expulsion of Device 5 5
Component Falling 4 4
Flaked 4 4
Improper Flow or Infusion 4 4
Component or Accessory Incompatibility 4 4
Device Contamination with Chemical or Other Material 4 4
Device Dislodged or Dislocated 4 4
Activation, Positioning or Separation Problem 4 4
Infusion or Flow Problem 3 3
Activation Problem 3 3
Migration 3 3
Therapeutic or Diagnostic Output Failure 3 3
Pumping Problem 3 3
No Pressure 3 3
Positioning Failure 3 3
Backflow 3 3
Knotted 3 3
Overheating of Device 3 3
Difficult To Position 3 3
Product Quality Problem 3 3
Lack of Effect 3 3
Shipping Damage or Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Unsealed Device Packaging 2 2
Particulates 2 2
Unintended Collision 2 2
Defective Component 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1279 1279
No Clinical Signs, Symptoms or Conditions 1005 1005
Intracranial Hemorrhage 786 786
No Known Impact Or Consequence To Patient 416 416
No Patient Involvement 392 392
Death 317 317
Vasoconstriction 236 236
Thromboembolism 221 221
Hemorrhage, Subarachnoid 220 220
Hemorrhage/Bleeding 209 209
Vascular Dissection 203 203
Perforation of Vessels 192 192
Hemorrhage, Cerebral 184 184
Stroke/CVA 174 174
Foreign Body In Patient 169 169
Infarction, Cerebral 137 137
Device Embedded In Tissue or Plaque 134 134
Hematoma 117 117
Insufficient Information 93 93
Ischemia Stroke 92 92
Embolism/Embolus 85 85
Obstruction/Occlusion 85 85
Neurological Deficit/Dysfunction 83 83
Unspecified Nervous System Problem 82 82
Embolus 68 68
Swelling/ Edema 61 61
Edema 57 57
Perforation 48 48
Thrombosis/Thrombus 47 47
Occlusion 46 46
Thrombosis 45 45
Stenosis 40 40
Extravasation 39 39
Therapeutic Response, Decreased 37 37
Embolism 34 34
Thrombus 32 32
Rupture 32 32
Ischemia 31 31
Pseudoaneurysm 30 30
No Code Available 26 26
Fistula 25 25
Intimal Dissection 25 25
Hemorrhagic Stroke 23 23
Cerebral Edema 22 22
Paralysis 21 21
Headache 17 17
Hydrocephalus 17 17
Paresis 16 16
Respiratory Failure 16 16
Cognitive Changes 16 16
Dysphasia 15 15
Muscle Weakness 15 15
Patient Problem/Medical Problem 14 14
Reocclusion 13 13
Coma 12 12
Hernia 12 12
Brain Injury 12 12
No Information 12 12
Loss of consciousness 11 11
Hemorrhage, Intraventricular 11 11
Heart Failure/Congestive Heart Failure 10 10
Convulsion/Seizure 9 9
Fever 8 8
Low Blood Pressure/ Hypotension 8 8
Unspecified Infection 8 8
Anemia 8 8
Aneurysm 8 8
Aspiration/Inhalation 8 8
Sepsis 8 8
Seizures 7 7
Visual Impairment 7 7
Visual Disturbances 7 7
Atrial Fibrillation 7 7
High Blood Pressure/ Hypertension 7 7
Pain 7 7
Necrosis 7 7
Failure of Implant 6 6
Inflammation 6 6
Bradycardia 6 6
Pneumonia 6 6
Complaint, Ill-Defined 6 6
Ventilator Dependent 5 5
Numbness 5 5
Transient Ischemic Attack 5 5
Weakness 5 5
Foreign Body Reaction 5 5
Vessel Or Plaque, Device Embedded In 5 5
Speech Disorder 5 5
Blood Loss 5 5
Restenosis 4 4
Pulmonary Embolism 4 4
Death, Intrauterine Fetal 4 4
Injury 4 4
Confusion/ Disorientation 4 4
Nervous System Injury 3 3
Vomiting 3 3
Swelling 3 3
Renal Failure 3 3
Hypersensitivity/Allergic reaction 3 3
Arrhythmia 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Concentric Medical Inc II Dec-08-2014
2 Concentric Medical Inc II Sep-08-2014
3 IMPERATIVE CARE INC I Sep-29-2021
4 Micro Therapeutics Inc, Dba Ev3 Neurovascular I May-16-2018
5 Penumbra Inc. I Jan-18-2021
6 Penumbra Inc. I Jun-22-2017
7 Penumbra Inc. I Nov-24-2010
8 Stryker Neurovascular II Mar-31-2020
9 Stryker Neurovascular II Jan-14-2018
10 Stryker Neurovascular II Dec-05-2017
11 Stryker Neurovascular II Jul-29-2017
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