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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, angioplasty, peripheral, transluminal
Regulation Description Percutaneous catheter.
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS US CORP
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. DBA SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NATEC MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUALIMED USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2492 2493
2022 2155 2157
2023 1807 1813
2024 1913 1919
2025 2092 2094
2026 311 311

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 6576 6583
Burst Container or Vessel 1425 1425
Difficult to Remove 705 709
Leak/Splash 639 640
Detachment of Device or Device Component 571 573
Break 388 391
Adverse Event Without Identified Device or Use Problem 359 361
Deflation Problem 319 320
Inflation Problem 319 319
Material Deformation 258 259
Material Separation 247 247
Difficult to Advance 207 207
Entrapment of Device 135 135
Improper or Incorrect Procedure or Method 135 136
Failure to Advance 131 131
Material Split, Cut or Torn 130 130
Fluid/Blood Leak 92 92
Material Puncture/Hole 92 92
Device-Device Incompatibility 82 82
Fracture 82 82
Material Integrity Problem 76 76
Material Twisted/Bent 70 70
Stretched 60 60
Difficult to Insert 46 46
Difficult to Open or Remove Packaging Material 44 45
Failure to Deflate 42 42
Material Frayed 37 37
Device Dislodged or Dislocated 34 35
Device Contamination with Chemical or Other Material 32 32
Off-Label Use 31 31
Partial Blockage 27 27
Use of Device Problem 24 24
Deformation Due to Compressive Stress 23 23
Device Damaged Prior to Use 22 22
Crack 20 20
Failure to Fold 19 19
Device Markings/Labelling Problem 18 19
Retraction Problem 18 18
Material Fragmentation 16 16
Device Damaged by Another Device 15 15
Component Missing 15 16
Tear, Rip or Hole in Device Packaging 14 14
Packaging Problem 13 13
Device Contaminated During Manufacture or Shipping 12 12
Physical Resistance/Sticking 10 10
Defective Component 10 10
Contamination 9 9
Loss of or Failure to Bond 9 9
Delivered as Unsterile Product 8 8
Suction Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9915 9930
Foreign Body In Patient 196 196
Insufficient Information 191 192
Vascular Dissection 153 153
No Consequences Or Impact To Patient 88 88
Perforation of Vessels 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
Embolism/Embolus 51 52
Hemorrhage/Bleeding 44 44
Device Embedded In Tissue or Plaque 43 43
Obstruction/Occlusion 41 41
Thrombosis/Thrombus 38 38
Stenosis 36 36
Hematoma 33 33
Restenosis 32 32
Pain 24 24
Unspecified Tissue Injury 22 22
Pseudoaneurysm 11 11
Stroke/CVA 10 10
Unspecified Infection 8 8
Fistula 8 8
Perforation 8 8
Extravasation 8 8
Sepsis 7 7
Vasoconstriction 7 7
Swelling/ Edema 6 6
Aneurysm 5 5
Ischemia 5 5
Rupture 5 5
Renal Failure 5 5
Myocardial Infarction 4 4
Calcium Deposits/Calcification 4 4
High Blood Pressure/ Hypertension 4 4
Arrhythmia 4 4
Pulmonary Embolism 3 3
Vomiting 3 3
Numbness 3 3
Low Blood Pressure/ Hypotension 3 3
Bradycardia 3 3
Cardiac Arrest 3 3
Shock 3 3
Necrosis 3 3
Diarrhea 2 2
Post Operative Wound Infection 2 2
Unspecified Vascular Problem 2 2
Asystole 2 2
Transient Ischemic Attack 2 2
Arteriosclerosis/ Atherosclerosis 2 2
Tachycardia 2 2
Hypoxia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jan-09-2026
2 Cordis Corporation II Aug-09-2021
3 Covidien LP II Oct-29-2024
4 Covidien Llc II Feb-03-2022
5 Ostial Corporation II Aug-17-2021
6 ev3 Inc II Jan-15-2025
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