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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device peripheral mechanical thrombectomy with aspiration
Regulation Description Embolectomy catheter.
Definition To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Product CodeQEW
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
2MG, INC.
  SUBSTANTIALLY EQUIVALENT 1
AKURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
AVANTEC VASCULAR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONTEGO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
DEVORO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
ENDOVASCULAR ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
ENDOVASCULAR ENGINEERING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXPANSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICHOR
  SUBSTANTIALLY EQUIVALENT 2
IMPERATIVE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 12
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 18
INNOVA VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
INQUIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
INTERVENE
  SUBSTANTIALLY EQUIVALENT 1
IRANI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, IRELAND
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 14
  SE - WITH LIMITATIONS 1
  1.  K192981  Indigo System Aspiration Catheter 12, Indigo Aspir ...
  2.  K193244  Indigo Aspiration System – Lightning Aspiration Tu ...
  3.  K193595  Indigo Aspiration System - Aspiration Catheter 7 a ...
  4.  K200771  Indigo Aspiration System Lightning Aspiration Tubi ...
  5.  K202821  Indigo Aspiration System - Aspiration Catheter 12 ...
  6.  K210083  Indigo System Aspiration Catheter 7, Indigo Aspira ...
  7.  K210323  Indigo Aspiration System - Lightning Aspiration Tu ...
  8.  K222358  Indigo Aspiration System - Lightning Flash
  9.  K223186  Indigo® Aspiration System – Lightning Bolt Aspirat ...
  10.  K240030  Indigo® Aspiration System - Lightning® Flash
  11.  K241399  Indigo® Lightning Flash Aspiration System – Select ...
  12.  K242075  Indigo® Aspiration System – Lightning Bolt Aspirat ...
  13.  K242319  Indigo® Aspiration System – Aspiration Catheter 6X
  14.  K252612  INDIGO® Aspiration System – Lightning Flash Aspira ...
SURMODICS,INC.
  SUBSTANTIALLY EQUIVALENT 5
TRUVIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR MEDCURE, INC.
  SUBSTANTIALLY EQUIVALENT 3
VESALIO
  SUBSTANTIALLY EQUIVALENT 1
VETEX MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 197 197
2021 322 322
2022 125 125
2023 165 165
2024 162 162
2025 208 208

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 217 217
Break 202 202
Physical Resistance/Sticking 163 163
Material Deformation 145 145
Fracture 130 130
Entrapment of Device 69 69
Obstruction of Flow 66 66
Electrical /Electronic Property Problem 47 47
Detachment of Device or Device Component 46 46
Use of Device Problem 43 43
Leak/Splash 39 39
Difficult to Remove 39 39
Improper or Incorrect Procedure or Method 36 36
Failure to Advance 35 35
Material Separation 32 32
Connection Problem 30 30
Suction Problem 25 25
Display or Visual Feedback Problem 20 20
Difficult to Advance 19 19
Suction Failure 17 17
Retraction Problem 14 14
Insufficient Information 12 12
Stretched 12 12
Circuit Failure 10 10
Fluid/Blood Leak 10 10
Patient-Device Incompatibility 7 7
Device Fell 7 7
Misconnection 6 6
Defective Device 6 6
Device Difficult to Setup or Prepare 6 6
Deformation Due to Compressive Stress 5 5
Migration 5 5
Pumping Problem 5 5
Material Twisted/Bent 5 5
Patient Device Interaction Problem 5 5
Material Fragmentation 5 5
Unraveled Material 5 5
Free or Unrestricted Flow 4 4
Activation, Positioning or Separation Problem 4 4
Mechanical Problem 4 4
Off-Label Use 4 4
Difficult to Insert 3 3
Failure to Power Up 3 3
Noise, Audible 3 3
Air/Gas in Device 3 3
Material Integrity Problem 3 3
Failure to Sense 3 3
Material Puncture/Hole 3 3
Material Split, Cut or Torn 3 3
Crack 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 743 743
No Consequences Or Impact To Patient 206 206
Pulmonary Embolism 60 60
Cardiac Arrest 55 55
Perforation of Vessels 43 43
Vascular Dissection 42 42
Foreign Body In Patient 40 40
Low Blood Pressure/ Hypotension 36 36
Hemoptysis 34 34
Great Vessel Perforation 25 25
Device Embedded In Tissue or Plaque 20 20
Low Oxygen Saturation 18 18
Hemorrhage/Bleeding 18 18
Respiratory Arrest 18 18
Anemia 18 18
Cardiac Perforation 18 18
Insufficient Information 15 15
Loss of consciousness 13 13
Thromboembolism 12 12
Hypoxia 12 12
Cardiogenic Shock 12 12
Pericardial Effusion 12 12
Tachycardia 11 11
Bradycardia 11 11
Intraoperative Pain 10 10
Cardiovascular Insufficiency 10 10
Thrombosis/Thrombus 10 10
Cardiac Tamponade 9 9
High Blood Pressure/ Hypertension 8 8
Embolism/Embolus 8 8
Hypovolemia 7 7
Cardiopulmonary Arrest 7 7
Unspecified Vascular Problem 6 6
Death 6 6
Hematoma 6 6
Extravasation 5 5
Discomfort 5 5
Pain 4 4
Chest Pain 4 4
Intracranial Hemorrhage 4 4
Obstruction/Occlusion 4 4
Vessel Or Plaque, Device Embedded In 4 4
Abdominal Pain 4 4
Stroke/CVA 4 4
Hypovolemic Shock 3 3
Abdominal Distention 3 3
Dyspnea 3 3
Perforation 3 3
Ischemia 3 3
Renal Failure 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Inari Medical - Oak Canyon II May-06-2025
2 Inari Medical - Oak Canyon I Aug-21-2024
3 Mermaid Medical A/S II Jun-26-2024
4 TELEFLEX MEDICAL INC I Feb-15-2022
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