Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 4
CARDIOVASCUALR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXIMO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 6
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 2931
2022 566 572
2023 574 576
2024 677 680
2025 624 624

Device Problems MDRs with this Device Problem Events in those MDRs
Break 868 1481
Detachment of Device or Device Component 742 987
Adverse Event Without Identified Device or Use Problem 592 1568
Entrapment of Device 512 517
Material Deformation 322 445
Material Separation 319 319
Mechanical Jam 295 296
Difficult to Remove 258 258
Physical Resistance/Sticking 254 255
Mechanical Problem 148 148
Suction Problem 123 123
Fracture 118 120
Difficult to Advance 92 92
Leak/Splash 89 89
Noise, Audible 89 89
Retraction Problem 83 83
Device Damaged by Another Device 81 81
Failure to Advance 63 63
Deformation Due to Compressive Stress 55 55
Unexpected Shutdown 45 45
Positioning Problem 35 35
Improper or Incorrect Procedure or Method 35 35
Use of Device Problem 33 33
Stretched 33 33
Defective Device 31 31
Overheating of Device 30 30
Device Markings/Labelling Problem 28 30
Device-Device Incompatibility 24 24
Material Split, Cut or Torn 22 22
Fluid/Blood Leak 22 22
Activation Problem 19 19
Melted 18 18
Off-Label Use 17 17
Intermittent Loss of Power 17 17
Material Integrity Problem 17 17
Insufficient Information 16 16
Unintended System Motion 15 15
Peeled/Delaminated 14 14
Flushing Problem 14 14
Material Puncture/Hole 14 14
Device Contamination with Chemical or Other Material 13 13
Device Difficult to Setup or Prepare 13 13
Device Contaminated at the User Facility 13 13
Difficult or Delayed Activation 13 13
Device Handling Problem 12 12
No Apparent Adverse Event 11 11
Display or Visual Feedback Problem 10 10
Output Problem 10 10
Device Displays Incorrect Message 9 9
Air/Gas in Device 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2269 2886
No Consequences Or Impact To Patient 271 271
Foreign Body In Patient 244 245
Embolism/Embolus 218 462
Vascular Dissection 195 562
Perforation of Vessels 173 295
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 139 140
Device Embedded In Tissue or Plaque 96 96
Insufficient Information 85 87
Perforation 72 72
No Known Impact Or Consequence To Patient 70 192
Obstruction/Occlusion 66 66
Unintended Radiation Exposure 64 918
Thrombosis/Thrombus 64 64
Pain 42 42
Stenosis 39 39
Hemorrhage/Bleeding 31 31
Hematoma 30 30
Pseudoaneurysm 29 29
Embolism 28 150
Restenosis 21 21
Unspecified Tissue Injury 20 20
Aneurysm 20 20
Vessel Or Plaque, Device Embedded In 19 19
Vasoconstriction 18 18
Radiation Exposure, Unintended 18 140
Vascular System (Circulation), Impaired 17 17
Iatrogenic Source 14 14
Injury 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
Low Blood Pressure/ Hypotension 7 7
Renal Failure 7 7
Thromboembolism 6 6
Cardiac Arrest 6 6
Intimal Dissection 6 6
Reocclusion 6 6
Sepsis 5 5
Swelling/ Edema 5 5
Hypersensitivity/Allergic reaction 5 5
Stroke/CVA 5 5
Intraoperative Pain 4 4
Foreign Body Embolism 4 4
Arteriosclerosis/ Atherosclerosis 3 3
Unspecified Infection 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
-
-