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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
Regulation Description Percutaneous catheter.
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 4
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
CERENOVUS INC.
  SUBSTANTIALLY EQUIVALENT 1
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 3
IMPERATIVE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS INC. D/B/A EV3 NEUROVASCULAR
  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 7
PERFUZE LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 703 703
2021 688 688
2022 549 549
2023 711 711
2024 641 641
2025 156 156

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1566 1566
Break 576 576
Physical Resistance/Sticking 542 542
Fracture 315 315
Material Deformation 260 260
Stretched 165 165
Difficult to Remove 127 127
Failure to Advance 106 106
Material Separation 85 85
Retraction Problem 77 77
Material Twisted/Bent 62 62
Difficult to Advance 42 42
Crack 41 41
Suction Problem 40 40
Unraveled Material 35 35
Suction Failure 33 33
Fluid/Blood Leak 32 32
No Apparent Adverse Event 30 30
Detachment of Device or Device Component 29 29
Material Puncture/Hole 24 24
Separation Failure 19 19
Leak/Splash 18 18
Patient-Device Incompatibility 13 13
Entrapment of Device 12 12
Peeled/Delaminated 10 10
Packaging Problem 10 10
Material Split, Cut or Torn 9 9
Use of Device Problem 9 9
Activation Failure 8 8
Unclear Information 8 8
Premature Separation 7 7
Appropriate Term/Code Not Available 6 6
Power Problem 5 5
Misconnection 5 5
Material Frayed 5 5
Device Fell 5 5
Insufficient Information 5 5
Deformation Due to Compressive Stress 4 4
Activation, Positioning or Separation Problem 4 4
Device Handling Problem 4 4
Activation Problem 4 4
Migration 4 4
Device Contamination with Body Fluid 4 4
Component or Accessory Incompatibility 3 3
Component Missing 3 3
Decrease in Suction 3 3
Lack of Effect 3 3
Unintended Movement 3 3
Connection Problem 3 3
Device Dislodged or Dislocated 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1312 1312
Intracranial Hemorrhage 658 658
No Consequences Or Impact To Patient 360 360
Thromboembolism 172 172
Hemorrhage/Bleeding 167 167
Vascular Dissection 157 157
Perforation of Vessels 148 148
Ischemia Stroke 141 141
Stroke/CVA 140 140
Foreign Body In Patient 135 135
Vasoconstriction 134 134
Insufficient Information 110 110
Embolism/Embolus 103 103
Obstruction/Occlusion 98 98
Unspecified Nervous System Problem 95 95
Hematoma 89 89
Thrombosis/Thrombus 70 70
Swelling/ Edema 67 67
Device Embedded In Tissue or Plaque 59 59
Death 56 56
Hemorrhagic Stroke 37 37
Extravasation 33 33
Cerebral Edema 32 32
Hemorrhage, Subarachnoid 30 30
Stenosis 30 30
Ischemia 30 30
No Known Impact Or Consequence To Patient 29 29
Rupture 28 28
Pseudoaneurysm 25 25
Fistula 24 24
Perforation 24 24
Infarction, Cerebral 22 22
Muscle Weakness 21 21
Paralysis 17 17
Dysphasia 17 17
Hemorrhage, Cerebral 16 16
Cognitive Changes 14 14
Embolus 12 12
Respiratory Failure 12 12
Paresis 12 12
Coma 12 12
Headache 11 11
Nervous System Injury 11 11
No Code Available 11 11
Hydrocephalus 10 10
Heart Failure/Congestive Heart Failure 10 10
Occlusion 10 10
Convulsion/Seizure 9 9
Aspiration/Inhalation 8 8
Unspecified Infection 8 8

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 Qapel Medical Inc. I Apr-07-2025
5 ROUTE 92 MEDICAL INC I Apr-24-2024
6 Scientia Vascular, Inc. II Feb-26-2025
7 Stryker Neurovascular II May-28-2024
8 Stryker Neurovascular II Mar-31-2020
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