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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
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
  SUBSTANTIALLY EQUIVALENT 1
DK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFINITY ANGIOPLASTY BALLOON COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR,INC(FORMERLY D.B.A EV3 INC.,COVIDIEN LLC)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC. (FORMERLY D.B.A. EV3 INC, COVIDIEN LLC.)
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
NATEC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEXSTEP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
2019 2405 2405
2020 2443 2443
2021 2492 2492
2022 2155 2155
2023 1806 1806
2024 1257 1257

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 7723 7723
Burst Container or Vessel 1793 1793
Difficult to Remove 697 697
Leak/Splash 681 681
Detachment of Device or Device Component 673 673
Adverse Event Without Identified Device or Use Problem 397 397
Break 394 394
Inflation Problem 313 313
Deflation Problem 311 311
Material Separation 283 283
Material Deformation 252 252
Difficult to Advance 180 180
Failure to Advance 150 150
Improper or Incorrect Procedure or Method 136 136
Entrapment of Device 125 125
Material Puncture/Hole 114 114
Material Split, Cut or Torn 102 102
Material Twisted/Bent 92 92
Retraction Problem 89 89
Device-Device Incompatibility 84 84
Material Integrity Problem 78 78
Fluid/Blood Leak 74 74
Fracture 67 67
Off-Label Use 49 49
Difficult to Insert 48 48
Use of Device Problem 47 47
Material Frayed 46 46
Stretched 44 44
Device Dislodged or Dislocated 41 41
Difficult to Open or Remove Packaging Material 33 33
Failure to Deflate 32 32
Partial Blockage 29 29
Device Handling Problem 27 27
Peeled/Delaminated 26 26
Packaging Problem 24 24
Failure to Fold 23 23
Structural Problem 22 22
Device Contamination with Chemical or Other Material 22 22
Crack 21 21
Device Damaged by Another Device 20 20
Device Markings/Labelling Problem 20 20
Device Damaged Prior to Use 19 19
Physical Resistance/Sticking 16 16
Device Contaminated During Manufacture or Shipping 13 13
Deformation Due to Compressive Stress 13 13
Defective Component 12 12
Unraveled Material 12 12
Component Missing 12 12
Mechanical Jam 10 10
Component Misassembled 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7244 7244
No Consequences Or Impact To Patient 4150 4151
Insufficient Information 164 164
Foreign Body In Patient 159 159
Vascular Dissection 150 150
No Known Impact Or Consequence To Patient 141 141
No Patient Involvement 111 111
Device Embedded In Tissue or Plaque 89 89
Stenosis 74 74
Injury 54 54
No Code Available 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Perforation of Vessels 48 48
Embolism/Embolus 44 44
Hematoma 43 43
Hemorrhage/Bleeding 42 42
Patient Problem/Medical Problem 37 37
Thrombosis/Thrombus 34 34
Obstruction/Occlusion 33 33
Restenosis 29 29
Pain 26 26
Unspecified Tissue Injury 21 21
Thrombus 20 20
Perforation 18 18
Death 18 18
Occlusion 17 17
Stroke/CVA 15 15
Pseudoaneurysm 14 14
Embolism 14 14
Thrombosis 12 12
Great Vessel Perforation 10 10
Reocclusion 10 10
Rupture 9 9
Unspecified Infection 9 9
Myocardial Infarction 8 8
Arrhythmia 8 8
Low Blood Pressure/ Hypotension 8 8
Extravasation 7 7
Calcium Deposits/Calcification 7 7
Fistula 7 7
Aneurysm 6 6
No Information 6 6
Ischemia 6 6
Blood Loss 6 6
Swelling/ Edema 6 6
Needle Stick/Puncture 6 6
Renal Failure 5 5
Bradycardia 5 5
Intimal Dissection 5 5
Vessel Or Plaque, Device Embedded In 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jan-30-2020
2 BrosMed Medical Co.,Ltd. II Feb-27-2019
3 Cordis Corporation II Aug-09-2021
4 Cordis Corporation II Feb-28-2020
5 Cordis Corporation II Oct-30-2019
6 Covidien Llc II Feb-03-2022
7 Nucryo Vascular Inc. II Nov-21-2019
8 Ostial Corporation II Aug-17-2021
9 ev3 Inc. II Sep-30-2020
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