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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
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 712 712
2024 442 442

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1576 1576
Break 674 674
Physical Resistance/Sticking 554 554
Material Deformation 351 351
Fracture 302 302
Stretched 205 205
Failure to Advance 147 147
Difficult to Remove 140 140
Suction Problem 79 79
Material Twisted/Bent 75 75
Material Separation 72 72
Retraction Problem 67 67
Difficult to Advance 50 50
Unraveled Material 44 44
Suction Failure 35 35
Crack 34 34
No Apparent Adverse Event 33 33
Device Damaged Prior to Use 29 29
Detachment of Device or Device Component 29 29
Material Puncture/Hole 24 24
Fluid/Blood Leak 23 23
Leak/Splash 18 18
Separation Failure 16 16
Patient-Device Incompatibility 13 13
Entrapment of Device 11 11
Premature Separation 11 11
Peeled/Delaminated 11 11
Pressure Problem 11 11
Material Split, Cut or Torn 10 10
Misconnection 10 10
Appropriate Term/Code Not Available 10 10
Packaging Problem 9 9
Unclear Information 8 8
Power Problem 8 8
Device Fell 7 7
Collapse 7 7
Activation Failure 7 7
Device Contamination with Body Fluid 7 7
Insufficient Information 6 6
Device Handling Problem 6 6
Material Frayed 6 6
Use of Device Problem 6 6
Failure to Power Up 6 6
Deformation Due to Compressive Stress 6 6
Mechanical Problem 6 6
Noise, Audible 5 5
Connection Problem 5 5
Component Missing 4 4
Material Fragmentation 4 4
Component or Accessory Incompatibility 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1107 1107
No Consequences Or Impact To Patient 764 764
Intracranial Hemorrhage 642 642
Thromboembolism 165 165
Hemorrhage/Bleeding 154 154
Vascular Dissection 154 154
Vasoconstriction 150 150
Stroke/CVA 138 138
Perforation of Vessels 138 138
Foreign Body In Patient 129 129
Ischemia Stroke 123 123
Insufficient Information 100 100
Embolism/Embolus 95 95
Obstruction/Occlusion 94 94
Unspecified Nervous System Problem 89 89
Hematoma 82 82
Death 81 81
Device Embedded In Tissue or Plaque 76 76
No Known Impact Or Consequence To Patient 64 64
Swelling/ Edema 63 63
No Patient Involvement 62 62
Thrombosis/Thrombus 52 52
Hemorrhage, Subarachnoid 41 41
Infarction, Cerebral 38 38
Stenosis 33 33
Cerebral Edema 31 31
Rupture 29 29
Hemorrhage, Cerebral 28 28
Hemorrhagic Stroke 27 27
Pseudoaneurysm 27 27
Extravasation 26 26
Ischemia 25 25
Perforation 24 24
Fistula 23 23
Muscle Weakness 19 19
Embolus 18 18
Paralysis 16 16
No Code Available 15 15
Cognitive Changes 15 15
Respiratory Failure 14 14
Occlusion 14 14
Dysphasia 14 14
Paresis 12 12
Headache 12 12
Therapeutic Response, Decreased 11 11
Coma 11 11
Edema 10 10
Heart Failure/Congestive Heart Failure 10 10
Hydrocephalus 10 10
Convulsion/Seizure 9 9

Recalls
Manufacturer Recall Class Date Posted
1 IMPERATIVE CARE INC I Sep-29-2021
2 MICROVENTION INC. II Sep-17-2024
3 Penumbra Inc. I Jan-18-2021
4 ROUTE 92 MEDICAL INC I Apr-24-2024
5 Stryker Neurovascular II May-28-2024
6 Stryker Neurovascular II Mar-31-2020
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