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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, embolectomy
Regulation Description Embolectomy catheter.
Product CodeDXE
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 3
MIVI NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 547 547
2021 333 333
2022 463 463
2023 436 436
2024 378 378
2025 136 136

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 482 482
Material Fragmentation 344 344
Break 250 250
Adverse Event Without Identified Device or Use Problem 215 215
Material Deformation 159 159
Detachment of Device or Device Component 129 129
Leak/Splash 117 117
Suction Problem 105 105
Display or Visual Feedback Problem 104 104
Deflation Problem 100 100
Physical Resistance/Sticking 94 94
Material Separation 62 62
Failure to Deflate 53 53
Burst Container or Vessel 47 47
Inflation Problem 41 41
Device Difficult to Setup or Prepare 38 38
Entrapment of Device 35 35
Material Puncture/Hole 34 34
Material Disintegration 31 31
Failure to Advance 31 31
Degraded 29 29
Difficult to Remove 26 26
Pumping Problem 21 21
Defective Device 19 19
Mechanical Problem 14 14
Material Split, Cut or Torn 14 14
Stretched 14 14
Appropriate Term/Code Not Available 12 12
Material Twisted/Bent 12 12
Difficult to Advance 11 11
Material Integrity Problem 11 11
Suction Failure 10 10
Fluid/Blood Leak 10 10
Material Perforation 8 8
Fracture 6 6
Device Damaged Prior to Use 5 5
Device Displays Incorrect Message 5 5
Deformation Due to Compressive Stress 5 5
Separation Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Difficult to Insert 5 5
Crack 4 4
Device Contamination with Chemical or Other Material 4 4
Failure to Prime 4 4
Mechanical Jam 4 4
Unraveled Material 4 4
Migration 3 3
Device Dislodged or Dislocated 3 3
Nonstandard Device 3 3
Decrease in Suction 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1604 1604
No Consequences Or Impact To Patient 359 359
No Known Impact Or Consequence To Patient 84 84
Insufficient Information 55 55
Foreign Body In Patient 52 52
Device Embedded In Tissue or Plaque 30 30
No Patient Involvement 23 23
Stroke/CVA 19 19
Low Blood Pressure/ Hypotension 17 17
Vascular Dissection 16 16
Cardiac Tamponade 16 16
Hemorrhage/Bleeding 15 15
Embolism/Embolus 15 15
Thrombosis/Thrombus 14 14
Death 12 12
Intracranial Hemorrhage 12 12
Myocardial Infarction 9 9
Hemorrhage, Cerebral 9 9
Perforation of Vessels 8 8
Bradycardia 7 7
Foreign Body Embolism 7 7
Pericardial Effusion 7 7
Vasoconstriction 7 7
Hematoma 7 7
Perforation 6 6
Obstruction/Occlusion 6 6
Hemorrhage, Subarachnoid 6 6
Ischemia 5 5
Pulmonary Embolism 5 5
Pain 5 5
No Code Available 5 5
Cardiac Perforation 5 5
Thromboembolism 5 5
Stenosis 4 4
Infarction, Cerebral 4 4
Renal Failure 4 4
Heart Failure/Congestive Heart Failure 4 4
Laceration(s) 4 4
Rupture 4 4
Thrombus 4 4
Thrombosis 3 3
Failure of Implant 3 3
Pseudoaneurysm 3 3
Unspecified Infection 3 3
Injury 3 3
Transient Ischemic Attack 3 3
Cardiac Arrest 3 3
Tricuspid Valve Insufficiency/ Regurgitation 3 3
Edema 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp I May-07-2020
2 Arrow International Inc I Nov-18-2021
3 Edwards Lifesciences, LLC II Nov-06-2023
4 Edwards Lifesciences, LLC II Oct-28-2022
5 INARI MEDICAL II Jun-09-2020
6 LeMaitre Vascular, Inc. II May-12-2025
7 LeMaitre Vascular, Inc. II May-15-2024
8 LeMaitre Vascular, Inc. II Nov-11-2022
9 LeMaitre Vascular, Inc. I Apr-01-2020
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