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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, peripheral, atherectomy
Regulation Description Intraluminal artery stripper.
Product CodeMCW
Regulation Number 870.4875
Device Class 2


Premarket Reviews
ManufacturerDecision
AVINGER, INC.
  SUBSTANTIALLY EQUIVALENT 2
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIO FLOW INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIO FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOVASCUALR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 3
EXIMO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 4
EXIMO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 631 753
2021 734 2930
2022 566 566
2023 575 575
2024 679 679
2025 261 261

Device Problems MDRs with this Device Problem Events in those MDRs
Break 782 1392
Detachment of Device or Device Component 670 914
Adverse Event Without Identified Device or Use Problem 542 1518
Entrapment of Device 471 471
Material Separation 290 290
Material Deformation 278 400
Physical Resistance/Sticking 233 233
Difficult to Remove 228 228
Mechanical Jam 227 227
Mechanical Problem 143 143
Fracture 113 113
Suction Problem 110 110
Difficult to Advance 86 86
Noise, Audible 83 83
Device Damaged by Another Device 72 72
Leak/Splash 70 70
Retraction Problem 70 70
Failure to Advance 52 52
Unexpected Shutdown 39 39
Positioning Problem 35 35
Use of Device Problem 31 31
Deformation Due to Compressive Stress 31 31
Improper or Incorrect Procedure or Method 31 31
Device Markings/Labelling Problem 28 28
Defective Device 27 27
Stretched 24 24
Overheating of Device 24 24
Fluid/Blood Leak 20 20
Device-Device Incompatibility 18 18
Material Split, Cut or Torn 17 17
Material Integrity Problem 17 17
Off-Label Use 16 16
Melted 15 15
Activation Problem 15 15
Intermittent Loss of Power 15 15
Peeled/Delaminated 14 14
Material Puncture/Hole 14 14
Difficult or Delayed Activation 13 13
Device Difficult to Setup or Prepare 13 13
Device Contamination with Chemical or Other Material 13 13
Insufficient Information 11 11
No Apparent Adverse Event 11 11
Unintended System Motion 10 10
Flushing Problem 10 10
Device Handling Problem 10 10
Output Problem 9 9
Material Twisted/Bent 9 9
Display or Visual Feedback Problem 9 9
Device Displays Incorrect Message 9 9
Infusion or Flow Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1992 2602
No Consequences Or Impact To Patient 271 271
Foreign Body In Patient 223 223
Vascular Dissection 192 558
Embolism/Embolus 192 436
Perforation of Vessels 147 269
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 136 136
Device Embedded In Tissue or Plaque 90 90
Insufficient Information 82 82
Perforation 71 71
No Known Impact Or Consequence To Patient 70 192
Unintended Radiation Exposure 59 913
Thrombosis/Thrombus 57 57
Obstruction/Occlusion 48 48
Stenosis 38 38
Pain 36 36
Hematoma 29 29
Embolism 28 150
Pseudoaneurysm 28 28
Hemorrhage/Bleeding 24 24
Restenosis 21 21
Unspecified Tissue Injury 20 20
Vessel Or Plaque, Device Embedded In 19 19
Aneurysm 19 19
Radiation Exposure, Unintended 18 140
Vascular System (Circulation), Impaired 17 17
Vasoconstriction 17 17
Injury 14 14
Iatrogenic Source 14 14
Ischemia 13 13
Myocardial Infarction 12 12
Fistula 12 12
No Code Available 11 11
Rupture 10 10
Extravasation 8 8
Occlusion 7 7
Cardiac Arrest 6 6
Thromboembolism 6 6
Low Blood Pressure/ Hypotension 6 6
Intimal Dissection 6 6
Renal Failure 6 6
Reocclusion 6 6
Swelling/ Edema 5 5
Sepsis 5 5
Hypersensitivity/Allergic reaction 5 5
Stroke/CVA 5 5
Intraoperative Pain 4 4
Foreign Body Embolism 4 4
Blood Loss 3 3
Fever 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Dec-27-2024
2 Bard Peripheral Vascular Inc I Mar-05-2025
3 Cardiovascular Systems Inc II Aug-28-2021
4 Spectranetics Corporation II Dec-16-2024
5 Spectranetics Corporation II Dec-08-2023
6 ev3 Inc. I Mar-07-2022
7 ev3 Inc. I Jan-19-2022
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